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 2009-07-23

VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN

Applicant Medcomp

K number K091586

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LJS 2009-07-01

BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER

Applicant Becton, Dickinson & CO

K number K091670

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LJS 2009-06-17

1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50

Applicant Medcomp

K number K091466

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LJS 2009-05-12

NMI PICC

Applicant Navilyst Medical, Inc.

K number K091261

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LJS 2009-05-01

FLOWPICC CATHETER

Applicant Vasonova, Inc.

K number K083920

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LJS 2009-03-19

PICC (CT RATED AND NON-RATED)

Applicant Pfm Medical, Inc.

K number K083873

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LJS 2009-03-16

ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN

Applicant R4 Vascular, Inc.

K number K083763

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LJS 2008-12-17

FLOWPICC CATHETER

Applicant Vasonova, Inc.

K number K082481

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LJS 2008-09-23

PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)

Applicant Medcomp

K number K081904

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LJS 2008-06-27

PRESSURE INJFECTABLE PICC

Applicant Arrow International, Inc.

K number K080604

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LJS 2008-01-15

PRESSURE INJECTABLE PICC

Applicant Arrow International, Inc.

K number K073451

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LJS 2007-12-20

CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)

Applicant Crs Medical Diagnostics, Inc.

K number K072518

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LJS 2007-12-13

TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)

Applicant Cook, Inc.

K number K072625

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LJS 2007-11-26

PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY

Applicant Medcomp

K number K072509

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LJS 2007-11-19

PFM PICC

Applicant Pfm Medical, Inc.

K number K072391

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LJS 2007-11-05

V-CATH POLY PICC

Applicant Hdc Corp.

K number K071875

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LJS 2007-10-05

POWERPICC SOLO

Applicant C.R. Bard, Inc.

K number K072230

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LJS 2007-08-27

ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT

Applicant AngioDynamics, Inc.

K number K072196

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LJS 2007-08-20

R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005

Applicant R4 Vascular, Inc.

K number K071361

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LJS 2007-08-17

BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER

Applicant Boston Scientific

K number K070002

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LJS 2007-06-29

ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT

Applicant AngioDynamics, Inc.

K number K070613

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LJS 2007-05-08

4 FR SINGLE LUMEN (SL) POWERPICC CATHETER

Applicant C.R. Bard, Inc.

K number K070996

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LJS 2007-05-07

FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE

Applicant Flexicath , Ltd.

K number K063363

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LJS 2007-05-04

ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT

Applicant AngioDynamics, Inc.

K number K070615

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LJS 2007-04-04

POWERGROSHONG PICC CATHETER

Applicant C.R. Bard, Inc.

K number K063848

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LJS 2006-11-28

OMNIPICC P.I.

Applicant Rita Medical Systems, Inc.

K number K062579

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LJS 2006-11-21

SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR

Applicant C.R. Bard, Inc.

K number K063240

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LJS 2006-09-15

LIFECATH S PICC AND MIDLINE CATHETER

Applicant Vygon Corp.

K number K062425

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LJS 2006-09-14

VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS

Applicant Vygon Us, LLC

K number K052475

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LJS 2006-08-24

ARROW PRESSURE INJECTABLE PICC

Applicant Arrow International, Inc.

K number K061289

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LJS 2006-08-09

KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311

Applicant The Kendall Company

K number K061936

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LJS 2006-08-09

POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER

Applicant C.R. Bard, Inc.

K number K061179

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LJS 2006-08-03

1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50

Applicant Medcomp

K number K061986

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LJS 2006-06-02

SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES

Applicant Lucent Medical Systems

K number K061240

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LJS 2006-04-28

ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT

Applicant AngioDynamics, Inc.

K number K060887

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LJS 2006-03-17

PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D

Applicant Medcomp

K number K053345

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LJS 2006-01-13

POWERPICC

Applicant Bard Access Systems, Inc.

K number K053501

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LJS 2005-11-23

POWERPICC

Applicant Bard Access Systems, Inc.

K number K051672

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LJS 2005-11-23

OMNIPICC PI

Applicant Rita Medical Systems, Inc.

K number K051102

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LJS 2005-10-20

POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE

Applicant C.R. Bard, Inc.

K number K051991

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LJS 2005-08-26

FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH

Applicant Crs Medical Diagnostics, Inc.

K number K050889

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LJS 2005-08-19

VYGON NUTRILINE CATHETERS

Applicant Vygon Corp.

K number K051690

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LJS 2005-07-26

MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER

Applicant Marian Medical, Inc.

K number K050542

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LJS 2005-07-25

BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669

Applicant Becton, Dickinson & CO

K number K051194

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LJS 2005-07-21

TURBO-FLO PICC

Applicant Cook, Inc.

K number K041849

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LJS 2005-06-30

6 FR FL POWERHOHN AND POWERLINE CATHETER

Applicant C.R. Bard, Inc.

K number K051417

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LJS 2005-06-15

6 FR DL POWERPICC CATHETER

Applicant C.R. Bard, Inc.

K number K050931

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LJS 2005-05-26

POWERHOHN AND POWERLINE CATHETERS

Applicant C.R. Bard, Inc.

K number K050185

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LJS 2005-01-14

6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC

Applicant C.R. Bard, Inc.

K number K043502

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LJS 2004-12-22

NEOSCI MEDICAL ENDOLUMINAL BRUSH

Applicant Neosci Medical, Inc.

K number K030400

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LJS 2004-12-10

KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304

Applicant Kendall

K number K042461

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LJS 2004-11-22

BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER

Applicant Becton, Dickinson & CO

K number K042491

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LJS 2004-11-01

TRIFUSION, MODEL 0609190/0659350

Applicant C.R. Bard, Inc.

K number K041088

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LJS 2004-09-09

PREMICATH, 1261.205

Applicant Vygon Corp.

K number K041468

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LJS 2004-08-27

PICC

Applicant Arrow Intl., Inc.

K number K042126

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LJS 2004-07-26

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

Applicant AngioDynamics, Inc.

K number K041420

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LJS 2004-03-19

POWERPICC CATHETERS, MODELS 3175155, 3175135

Applicant C.R. Bard, Inc.

K number K033389

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LJS 2004-03-05

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

Applicant AngioDynamics, Inc.

K number K040446

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LJS 2004-01-21

GROSHONG NXT PICC CATHETERS

Applicant C.R. Bard, Inc.

K number K034020

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LJS 2004-01-21

POLY PER-Q-CATH PICC CATHETERS

Applicant C.R. Bard, Inc.

K number K034019

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LJS 2003-07-02

LIFEVALVE CENTRAL VENOUS CATHTER

Applicant Horizon Medical Products, Inc.

K number K031718

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LJS 2003-06-19

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

Applicant AngioDynamics, Inc.

K number K031626

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LJS 2003-05-05

POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC

Applicant C.R. Bard, Inc.

K number K031129

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LJS 2003-04-30

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

Applicant AngioDynamics, Inc.

K number K030415

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LJS 2003-04-11

3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON

Applicant Medcomp

K number K030270

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LJS 2003-02-07

SILICONE DUAL LUMEN RADPICC CATHETERS

Applicant C.R. Bard, Inc.

K number K030255

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LJS 2002-12-18

GROSHONG NXT DUAL LUMEN PICC CATHETERS

Applicant C.R. Bard, Inc.

K number K023374

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LJS 2002-06-06

VAXCEL PICC WITH PASV VALVE TECHNOLOGY

Applicant Catheter Innovations, Inc.

K number K021704

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LJS 2001-10-15

FAS ENDOLUMINAL BRUSH

Applicant Fas Medical , Ltd.

K number K012641

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LJS 2001-09-10

POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100

Applicant C.R. Bard, Inc.

K number K012902

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LJS 2001-08-01

CENTRAL VENOUS CATHETER

Applicant Boston Scientific Corp

K number K003839

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LJS 2001-02-28

DUAL LUMEN MIDLINE CATHETER

Applicant Catheter Innovations, Inc.

K number K010349

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LJS 2001-01-26

MEDCOMP Z-CATH

Applicant Medical Components, Inc.

K number K003682

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LJS 2000-12-29

SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20

Applicant Plastimed Laboratoire Pharmaceutique

K number K992424

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LJS 2000-12-20

PLACEMENT-PLUS

Applicant Catheter Innovations, Inc.

K number K003642

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LJS 2000-12-01

MEDCOMP BIO-CATH CATHETER LINE

Applicant Medcomp

K number K003110

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LJS 2000-09-25

PERIPHERALLY INSERTED CENTRAL CATHETER

Applicant Utah Medical Products, Inc.

K number K001874

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LJS 2000-09-19

POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135

Applicant C.R. Bard, Inc.

K number K001901

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LJS 2000-08-03

VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)

Applicant Vygon Corp.

K number K993442

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LJS 2000-08-03

VYGON 2 FR EPICUTANEO PUR-CATHETER

Applicant Vygon Corp.

K number K993052

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LJS 2000-01-18

FAS ENDOLUMINAL BRUSH

Applicant Fas Medical , Ltd.

K number K993614

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LJS 1999-01-13

VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)

Applicant Vygon Corp.

K number K983544

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LJS 1998-12-10

MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T

Applicant Medical Components, Inc.

K number K983412

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LJS 1998-03-24

ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)

Applicant Luther Medical Products, Inc.

K number K980090

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LJS 1997-12-22

CATHETER TUNNELER

Applicant Gerard Medical, Inc.

K number K972555

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LJS 1997-11-24

PERIPHERALLY INSERTED CENTRAL

Applicant B.Braun Medical, Inc.

K number K971999

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LJS 1997-11-12

1.4 FR MAPCATH SENSOR STYLET

Applicant Navion Biomedical Corp.

K number K973057

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LJS 1997-08-01

DOUBLE LUMEN PICC

Applicant B.Braun Medical, Inc.

K number K970926

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LJS 1997-06-26

CLINICATH IR PERIPHERALLY INSERTED CATHETER

Applicant Sims Deltec, Inc.

K number K970269

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LJS 1997-06-02

SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER

Applicant B.Braun Medical, Inc.

K number K971085

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LJS 1997-06-02

PERIPHERALLY INSERTED CENTRAL CATHETER

Applicant B.Braun Medical, Inc.

K number K964929

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LJS 1997-04-16

HR POLYURETHANE PICC AND MIDLINE CATHETERS

Applicant Johnson & Johnson Medical, Inc.

K number K964556

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LJS 1997-04-16

PICC CATHETER/MIDLINE CATHETER

Applicant Menlo Care, Inc.

K number K964447

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LJS 1997-04-01

NEO-PICC

Applicant Klein-Baker Medical, Inc.

K number K970434

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LJS 1997-03-04

PERIPHERALLY INSERTED MEDLINE CATHETER

Applicant Arrow Intl., Inc.

K number K963257

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LJS 1996-12-12

CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)

Applicant Bmw Medical, Inc.

K number K963806

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LJS 1996-11-14

CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)

Applicant Bmw Medical, Inc.

K number K963215

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LJS 1996-10-18

CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)

Applicant Bmw Medical, Inc.

K number K963097

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LJS 1996-10-07

CATHETER INSERTION TRAY

Applicant Medcare Medical Group, Inc.

K number K962849

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LJS 1996-09-30

MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932

Applicant Pudenz-Schulte Medical Research Corp.

K number K960055

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