Set, Administration, Intravascular

FDA product code FPA · 1138 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5440
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-16 – 2026-09-11

FPA 2017-01-06

Hospira Extension Set, Hospira Primary Set

Applicant Hospira, Inc.

K number K161036

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FPA 2016-12-19

Paclitaxel Sets

Applicant Baxter Healthcare Corporation

K number K160007

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FPA 2016-12-06

Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets

Applicant Quest Medical, Inc.

K number K162304

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FPA 2016-11-30

Solution Set for Epidural Use

Applicant Baxter Healthcare Corporation

K number K161323

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FPA 2016-08-25

LifeFlow Rapid Infusion Device (LifeFlow Device)

Applicant 410 Medical Innovation, LLC

K number K153731

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FPA 2016-08-18

PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set

Applicant C.R. Bard, Inc.

K number K153440

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FPA 2016-08-10

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

Applicant Unomedical A/S

K number K160648

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FPA 2016-06-07

Smart Set

Applicant Top Spins, Inc.

K number K151250

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FPA 2016-06-01

Hospira Administration Sets

Applicant Hospira, Inc.

K number K160870

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FPA 2016-04-12

Orbit Infusion Set

Applicant Ypsomed AG

K number K150921

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FPA 2016-04-07

BD FlowSmart Set, MiniMed Pro-Set

Applicant Becton, Dickinson and Company

K number K160651

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FPA 2016-04-06

Extension Set

Applicant B.Braun Medical, Inc.

K number K153293

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FPA 2016-01-19

Hospira Extension Sets

Applicant Icu Medical, Inc.

K number K151969

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FPA 2013-10-08

NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS

Applicant Baxter Healthcare Corp

K number K132734

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FPA 2013-10-08

NERIA SOFT 90 INFUSION SET

Applicant Unomedical A/S

K number K132142

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FPA 2013-08-29

MZ1000

Applicant Care Fusion

K number K132413

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FPA 2013-07-09

NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS

Applicant Nexus Medical, LLC

K number K130879

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FPA 2013-06-12

NEXUS TKO-6P LUER ACTIVATED DEVICE

Applicant Nexus Medical, LLC

K number K130416

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FPA 2013-05-06

MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26

Applicant Repro-Med Systems, Inc. Dba Rms Medical Products

K number K122404

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FPA 2013-04-03

K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR

Applicant Np Medical, Inc.

K number K130023

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FPA 2013-03-19

ORBIT INFUSION SET

Applicant Ypsomed AG

K number K130468

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FPA 2013-03-07

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)

Applicant Kawasumi Laboratories, Inc.

K number K123344

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FPA 2013-03-07

MACLIN POWER INTRAVASCULAR ADMINISTRATION SET

Applicant Maclin Power, Inc.

K number K121511

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FPA 2013-01-22

TBA

Applicant Migada Plant

K number K121269

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FPA 2013-01-10

INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S

Applicant Baxter Healthcare Corp

K number K123874

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FPA 2013-01-08

INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

Applicant Baxter Healthcare Corp

K number K123868

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FPA 2012-12-21

VERSARATE FLOW RATE CONTROLER

Applicant Emed Technologies Corporation

K number K123729

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FPA 2012-12-19

INTRAVASCULAR ADMINISTRATION SET

Applicant Acta Medical, LLC

K number K121803

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FPA 2012-11-16

ACCU-CHEK ULTRAFLEX INFUSION SET

Applicant Roche Diabetes Care AG

K number K122686

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FPA 2012-10-18

NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET

Applicant Nipro Medical Corporation

K number K113471

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FPA 2012-10-17

NIPRO SAFE TOUCH HUBER INFUSION SET

Applicant Nipro Medical Corporation

K number K113470

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FPA 2012-09-07

ZYNO MEDICAL ADMINISTRATION SET

Applicant Zyno Medical, LLC

K number K120685

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FPA 2012-07-06

SAFETY SUBCUTANEOUS TISSUE INFUSION SET

Applicant Multi Med

K number K120195

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FPA 2012-06-29

INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR

Applicant Baxter Healthcare Corporation

K number K121634

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FPA 2012-06-29

FLOWEASE [SUBCUTANEOUS] INFUSION SET

Applicant Baxter Healthcare Corp

K number K121092

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FPA 2012-06-28

MED-RX PATIENT DELIVERY SET

Applicant Benlan, Inc.

K number K120375

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FPA 2012-06-21

PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP

Applicant Hospira, Inc.

K number K121032

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FPA 2012-06-08

Q-FLO CLOSED MALE LUER CONNECTOR

Applicant Us Fusion, LLC. Dba Truecare Biomedix-USA

K number K121554

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FPA 2012-05-30

NERIA MULTI SUBCUTANEOUS INFUSION SET

Applicant Unomedical Devices S.A DE C.V.

K number K120395

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FPA 2012-05-22

NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE

Applicant Baxter Healthcare Corporation - Renal Division

K number K120443

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FPA 2012-05-04

HLIC NEEDLE-LESS VALVE

Applicant Health Line International Corporation

K number K120548

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FPA 2012-05-02

PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER

Applicant Perouse Medical

K number K120261

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FPA 2012-04-20

ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS

Applicant Unomedical A/S Infusion Devices

K number K120872

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FPA 2012-04-18

NEXUS TKO-6, LUER-ACTIVATED DEVICE

Applicant Nexus Medical, LLC

K number K113398

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FPA 2012-04-11

INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...

Applicant Rx Devices, LLC

K number K112073

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FPA 2012-03-30

ARISURE NEUTRAL VALVE

Applicant Yukon Medical, LLC

K number K120799

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FPA 2012-01-12

LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL

Applicant Hospira, Inc.

K number K113683

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FPA 2011-12-23

MED-RX EXTENSION SET WITH T-CONNECTOR

Applicant Benlan, Inc.

K number K112799

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FPA 2011-11-26

CYTOGUARD(TM) CLOSED LUER CONNECTOR

Applicant B.Braun Medical, Inc.

K number K112636

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FPA 2011-10-20

VANISHPOINT BLOOD COLLECTION SET

Applicant Retractable Technologies, Inc.

K number K112512

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FPA 2011-10-18

CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS

Applicant Baxter Healthcare Corporation

K number K112893

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FPA 2011-09-29

TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET

Applicant Us Infusion Dba Truecare Biomedix

K number K111351

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FPA 2011-07-21

INFUSION SET FOR POWERPICC SOLO 2 CATHETER

Applicant C.R. Bard, Inc.

K number K102405

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FPA 2011-06-23

CENTURION PRESSURE INJECTABLE EXTENSION SET

Applicant Centurion Medical Products Corporation

K number K103562

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FPA 2011-06-09

SAFEPORT MANIFOLD (TM) (OR STOPCOCK)

Applicant Elcam Medical Acal

K number K111016

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FPA 2011-05-20

RMS SUBCUTANEOUS NEEDLE SET

Applicant Repro-Med Systems, Inc.

K number K102512

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FPA 2011-04-27

LIGHTY DD INFUSION SET

Applicant Medx-Set, Ltd.

K number K110282

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FPA 2011-03-25

INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,

Applicant Baxter Healthcare Corp

K number K103551

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FPA 2011-01-07

HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING

Applicant Hospira, Inc.

K number K103224

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FPA 2010-12-17

HIGH PRESSURE SETS-400 PSI

Applicant Icu Medical, Inc.

K number K100576

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FPA 2010-12-10

INFUSION SETS

Applicant Hospira, Inc.

K number K103344

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FPA 2010-11-18

D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES

Applicant Dragon Heart Medical, Inc.

K number K101368

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FPA 2010-11-18

K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING

Applicant Kawasumi Laboratories, Inc.

K number K100720

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FPA 2010-11-10

BLOOD SAMPLING SET

Applicant Acacia, Inc.

K number K103165

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FPA 2010-11-08

MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS

Applicant Benlan, Inc.

K number K102073

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FPA 2010-10-21

K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)

Applicant Kawasumi Laboratories America, Inc.

K number K102890

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FPA 2010-09-29

AMSINO I.V. ADMINISTRATION AND EXTENSION SETS

Applicant Amsino International, Inc.

K number K101958

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FPA 2010-08-27

ACCU-CHEK ULTRFLEX INFUSION SET

Applicant Roche Diagnostics Corp.

K number K101196

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FPA 2010-08-11

HOSPIRA INFUSION BLOOD SETS

Applicant Hospira, Inc.

K number K101677

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FPA 2010-08-03

GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,

Applicant Smiths Medical MD, Inc.

K number K101180

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FPA 2010-08-02

INTRAVSCULAR ADMINISTRATION SET

Applicant Terumo Europe N.V.

K number K100946

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FPA 2010-07-29

IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY

Applicant Rymed Technologies, Inc.

K number K093489

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FPA 2010-07-09

CLAVE NEUTRON

Applicant Icu Medical, Inc.

K number K100434

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FPA 2010-07-09

POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS

Applicant Medtronic Minimed

K number K100432

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FPA 2010-06-22

DUAL LUER LOCK CAP, MODEL 2C6250

Applicant Baxter Healthcare Corp

K number K101385

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FPA 2010-04-26

NEXUS PRESSURE RATED EXTENSION SETS

Applicant Nexus Medical, LLC

K number K092382

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FPA 2010-03-10

AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS

Applicant Amsino International, Inc.

K number K093773

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FPA 2010-03-10

NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED

Applicant Nexus Medical, LLC

K number K092930

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FPA 2010-03-04

AUTOSTART BURETTE

Applicant Analytica Pty, Ltd.

K number K092905

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FPA 2010-02-04

NEXUS INJECTION SITE, MODEL NIS-8

Applicant Nexus Medical, LLC

K number K092527

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FPA 2010-01-27

EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD

Applicant Victus, Inc.

K number K093271

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FPA 2010-01-04

EXEL I.V. EXTENSION SET

Applicant Exelint Intl. Co.

K number K092172

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FPA 2009-10-13

DISPOSABLE TPE INFUSION SET

Applicant Shan Dong Wei Gao Group Medical Polymer Products

K number K090459

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FPA 2009-06-11

DISPOSABLE INFUSION SET

Applicant Shan Dong Wei Gao Group Medical Polymer Products

K number K090012

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FPA 2009-06-11

BAIXIN INTRAVASCULAR ADMINISTRATION SET

Applicant Anhui Kangda Medical Products Co., Ltd.

K number K083687

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FPA 2009-06-05

A6 LUER ACCESS DEVICE

Applicant B.Braun Medical, Inc.

K number K083723

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FPA 2009-04-28

MPS ACACIA POWER INJECTABLE INFUSION SET

Applicant Mps Acacia

K number K090809

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FPA 2009-04-21

INTRAVENOUS POWER INJECTOR EXTENSION SET

Applicant C.R. Bard, Inc.

K number K090134

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FPA 2009-04-10

ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE

Applicant Icu Medical, Inc.

K number K090189

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FPA 2009-04-06

SPINNING SPIROS, MODEL CH-2000

Applicant Icu Medical, Inc.

K number K082806

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FPA 2009-04-02

COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET

Applicant Cook Vascular, Inc.

K number K083482

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FPA 2009-02-13

FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160

Applicant Genesis Bps, LLC

K number K082027

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FPA 2008-12-30

MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL

Applicant Medegen Medical Manufacturing Services

K number K083765

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FPA 2008-12-23

MISER CONTRAST MANAGEMENT SYSTEM

Applicant Merit Medical Systems, Inc.

K number K083576

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FPA 2008-12-23

SUBCUTANEOUS NEEDLE INFUSION SET

Applicant Marcal Medical, Inc.

K number K082818

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FPA 2008-12-09

MEDEGEN PRESSURE RATED EXTENSION SETS

Applicant Medegen, Inc.

K number K083472

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FPA 2008-11-14

NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS

Applicant Nexus Medical, LLC

K number K081123

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FPA 2008-10-21

NIPRO SAFETOUCH HUBER INFUSTION SET

Applicant Nipro Medical Corp.

K number K081210

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FPA 2008-08-28

POWERLOC CLEAR SAFETY INFUSION SET

Applicant C.R. Bard, Inc.

K number K082306

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FPA 2008-08-28

CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX

Applicant Icu Medical, Inc.

K number K081361

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