Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

FDA product code LJS · 287 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5970
Review panel: HO
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1983-01-05 – 2026-04-17

LJS 2026-04-17

Neonav ECG Tip Location System

Applicant Navi Medical Technologies

K number K260929

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LJS 2025-12-16

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

Applicant Spectrum Vascular

K number K252373

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LJS 2025-11-17

PM2™ System with ECGuide™ Connector

Applicant Piccolo Medical, Inc.

K number K252792

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LJS 2025-08-01

HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr

Applicant Access Vascular, Inc.

K number K243458

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LJS 2025-07-01

Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)

Applicant Access Vascular, Inc.

K number K251212

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LJS 2025-05-29

PM2+ System and SmartPICC Stylet

Applicant Piccolo Medical, Inc.

K number K243484

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LJS 2025-02-26

pilot TLS

Applicant Vygon Corporation

K number K241587

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LJS 2025-01-19

Neonav ECG Tip Location System

Applicant Navi Medical Technologies

K number K241910

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LJS 2025-01-17

HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)

Applicant Access Vascular, Inc.

K number K243941

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LJS 2024-09-08

PM2 System and ECGuide Connector

Applicant Piccolo Medical, Inc.

K number K240486

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LJS 2023-12-01

CATHTONG III Tapered PICC Catheter

Applicant L&Z Us, Inc.

K number K233149

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LJS 2023-11-30

L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters

Applicant Argon Medical Devices

K number K230669

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LJS 2023-09-22

CATHTONG™ II PICC Catheter

Applicant L&Z Us, Inc.

K number K232594

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LJS 2023-09-22

CATHTONG™ II PICC Catheter

Applicant L&Z Us, Inc.

K number K232571

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LJS 2022-08-24

Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

Applicant Bard Access Systems, Inc.

K number K222232

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LJS 2022-08-22

VPS Rhythm DLX Device with TipTracker Technology

Applicant Arrow International, LLC (A subsidiary of Teleflex, Inc.)

K number K220363

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LJS 2022-05-04

HydroPICC 5F Dual Lumen Catheter

Applicant Access Vascular, Inc.

K number K213550

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LJS 2021-07-30

BD PowerPiCC Catheter

Applicant Bard Access Systems, Inc.

K number K210264

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LJS 2021-03-12

Groshong NXT PICC Catheter

Applicant C.R. Bard, Inc.

K number K201452

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LJS 2021-01-22

Piccolo Medical SmartPICC System

Applicant Piccolo Medical, Inc.

K number K200037

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LJS 2020-04-30

Biowy PICC Catheter S Kit

Applicant Biowy Corporation

K number K192246

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LJS 2020-02-20

HydroPICC (PICC-142)

Applicant Access Vascular, Inc.

K number K193015

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LJS 2018-11-21

Jet Power Injectable PICC

Applicant Jet Medical, Inc.

K number K180546

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LJS 2018-09-25

5 FR Dual Lumen Piper PICC

Applicant Piper Access, LLC

K number K181904

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LJS 2018-06-18

Sherlock 3CG+ T ip Confirmation System

Applicant C.R. Bard, Inc.

K number K180560

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LJS 2018-05-21

Biowy PlCC Catheter

Applicant Biowy Corporation

K number K173956

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LJS 2018-04-26

3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology

Applicant C.R. Bard, Inc (Bard Has Joined Bd)

K number K180548

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LJS 2018-04-20

Hickman TriFusion Catheter

Applicant C.R. Bard, Inc.

K number K172511

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LJS 2018-04-12

C3 Wave System

Applicant Medical Components, Inc. (dba MedComp)

K number K180567

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LJS 2018-02-26

Vygon PICCs

Applicant Vygon USA

K number K172899

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LJS 2018-02-22

Silicone Peripherally Inserted Central Venous Catheter Set/Tray

Applicant Cook Incorporated

K number K171994

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LJS 2018-02-20

HydroPICC

Applicant Access Vascular, Inc.

K number K172885

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LJS 2017-12-06

C3 Wave System

Applicant Medical Components, Inc (Dba Medcomp_

K number K170934

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LJS 2017-10-26

Celerity ECG Cable Accessory Pack

Applicant Medcomp (Medical Components, Inc.)

K number K171931

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LJS 2017-09-29

Sherlock 3CG Tip Positioning System Stylet

Applicant C.R. Bard, Inc.

K number K172397

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LJS 2017-08-03

CATHTONG II PICC Catheter

Applicant L&Z Us, Inc.

K number K172039

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LJS 2017-05-25

CATHTONG II PICC Catheter

Applicant L&Z Us, Inc.

K number K170486

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LJS 2017-04-24

PowerPICC Provena Catheters with SOLO Valve Technology

Applicant C.R. Bard, Inc.

K number K162441

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LJS 2017-02-03

PICC Maximal Barrier Nursing Kit

Applicant Navilyst Medical, Inc.

K number K163452

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LJS 2016-12-22

VPS Rhythm Device with TipTracker Technology

Applicant Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)

K number K160925

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LJS 2016-10-25

PowerPICC Provena Catheters

Applicant C.R. Bard, Inc.

K number K162443

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LJS 2016-10-07

Turbo-Flo PICC Sets

Applicant Cook Incorporated

K number K161496

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LJS 2016-09-06

CG+ Arrow JACC

Applicant Arrow International, Inc. (Subsidiary of Teleflex

K number K161765

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LJS 2016-09-01

Cathtong I PICC Catheter

Applicant L&Z Us, Inc.

K number K153469

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LJS 2016-06-14

PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter

Applicant C.R. Bard, Inc.

K number K151985

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LJS 2016-02-05

Amecath Peripheral inserted Central Venous Catheter Sets

Applicant Ameco Medical Industries

K number K152819

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LJS 2016-02-04

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS

Applicant Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K number K153487

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LJS 2016-01-28

CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

Applicant Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K number K153423

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LJS 2013-12-23

SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

Applicant Cook, Inc.

K number K133634

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LJS 2013-11-20

NMI PICC III

Applicant Navilyst Medical, Inc.

K number K133264

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LJS 2013-11-05

ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN

Applicant Covidien

K number K132567

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LJS 2013-10-22

MEDCOMP VASCU-PICC WITH VALVE

Applicant Medcomp ( Medical Components)

K number K130897

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LJS 2013-10-11

TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET

Applicant Cook Incorporated

K number K132885

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LJS 2013-08-16

TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET

Applicant Cook, Inc.

K number K132334

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LJS 2013-08-16

6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET

Applicant Medical Components, Inc.

K number K131687

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LJS 2013-07-31

NMI PICC III CATHETER, NMI HPICC III CATHETER

Applicant Navilyst Medical, Inc.

K number K131942

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LJS 2013-06-03

FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER

Applicant Footprint Medical, Inc.

K number K130507

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LJS 2013-05-15

3F PRO-PICC

Applicant Medical Components, Inc.

K number K123617

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LJS 2013-05-09

NMI PICC MAXIMAL BARRIER NURSING KITS

Applicant Navilyst Medical, Inc.

K number K131038

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LJS 2013-04-26

CG+ ARROW PICC POWERED BY ARROW VPS STYLET

Applicant Arrow International, Inc.

K number K130876

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LJS 2013-03-08

UNI-PICC

Applicant Health Line International Corporation

K number K130034

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LJS 2013-01-03

CG+ ARROW PICC POWERED BY ARROW VPS STYLET

Applicant Arrow International, Inc. (Subsidiary of Teleflex

K number K123759

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LJS 2012-12-12

VASU-PICC

Applicant Medical Components, Inc.

K number K122423

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LJS 2012-11-29

ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)

Applicant Arrow International (Subsidiary of Teleflex Inc.)

K number K121501

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LJS 2012-11-06

NYLUS PICC

Applicant Semprus Biosciences

K number K113225

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LJS 2012-10-18

NMI HPICC III

Applicant Navilyst Medical, Inc.

K number K122882

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LJS 2012-09-20

CG+ ARROW PICC POWERED BY ARROW VPS STYLET

Applicant Arrow International (Subsidiary of Teleflex Inc.)

K number K122545

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LJS 2012-09-07

ARROW PICC POWERED BY ARROW VPS STYLET

Applicant Arrow International (Subsidiary of Teleflex Inc.)

K number K121941

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LJS 2012-08-23

NMI PICC III

Applicant Navilyst Medical, Inc.

K number K121089

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LJS 2012-08-03

PICC CONVENIENCE KIT

Applicant Navilyst Medical, Inc.

K number K121990

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LJS 2012-06-21

ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS

Applicant Arrow International, Inc.

K number K113277

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LJS 2012-06-06

MEDCOMP VASCU-PICC & MIDLINE CATHETERS

Applicant Medical Components, Inc.

K number K121094

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LJS 2012-05-10

ARRW EVOLUTION

Applicant Arrow International (Subsidiary of Teleflex Inc.)

K number K112896

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LJS 2012-05-02

2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC

Applicant Medical Components, Inc.

K number K120981

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LJS 2012-05-02

1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC

Applicant Medical Components, Inc.

K number K120980

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LJS 2012-03-19

THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)

Applicant C.R. Bard, Inc.

K number K113808

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LJS 2011-12-20

DIRECT ANTIBIOTIC INFUSION KIT

Applicant Summit Medical Products, Inc.

K number K113043

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LJS 2011-10-20

SAPIENS TIP CONFIRMATION SYSTEM

Applicant C.R. Bard, Inc.

K number K112744

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LJS 2011-09-21

TRIPLE LUMEN PFM PICC

Applicant Pfm Medical, Inc.

K number K110914

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LJS 2011-08-12

NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER

Applicant Marvao Medical Devices, Ltd.

K number K110627

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LJS 2011-07-29

XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY

Applicant Navilyst Medical, Inc.

K number K111906

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LJS 2011-06-14

TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)

Applicant Cook, Inc.

K number K111244

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LJS 2010-12-21

2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC

Applicant Medcomp

K number K102966

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LJS 2010-11-17

POWERPICC SV CATHETERS

Applicant C.R. Bard, Inc.

K number K102159

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LJS 2010-09-02

NMI IC

Applicant Navilyst Medical, Inc.

K number K101326

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LJS 2010-08-27

ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504

Applicant Arrow Intl., Inc.

K number K100635

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LJS 2010-08-19

SYNERGY CT PICC

Applicant Health Line International Corporation

K number K101329

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LJS 2010-07-15

EVGUIDE TIP LOCATION SYSTEM

Applicant Romedex International Srl

K number K093775

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LJS 2010-07-09

SECURACATH UNIVERSAL

Applicant Interrad Medical, Inc.

K number K092306

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LJS 2010-03-25

MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519

Applicant AngioDynamics, Inc.

K number K093406

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LJS 2010-02-04

6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER

Applicant C.R. Bard, Inc.

K number K093927

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LJS 2009-12-17

FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER

Applicant Footprint Medical, Inc.

K number K093252

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LJS 2009-11-24

NMI PICC II

Applicant Navilyst Medical, Inc.

K number K093366

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LJS 2009-11-24

PRO-LINE CT (BASIC TRAY) MODEL MR28036101

Applicant Medcomp ( Medical Components)

K number K093309

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LJS 2009-11-18

PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240

Applicant R4 Vascular, Inc.

K number K092040

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LJS 2009-11-18

VPS CATHETER

Applicant Vasonova, Inc.

K number K091924

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LJS 2009-09-16

PRO-PICC CT

Applicant Medcomp

K number K092347

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LJS 2009-09-16

PRO-PICC

Applicant Medcomp

K number K091953

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LJS 2009-09-14

FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C

Applicant Footprint Medical

K number K091488

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LJS 2009-08-07

SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET

Applicant C.R. Bard, Inc.

K number K091324

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