Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

FDA product code FOZ · 489 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5200
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-20 – 2026-09-02

FOZ 2011-09-30

BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM

Applicant Becton, Dickinson and Company (BD)

K number K111366

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FOZ 2011-09-22

RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE

Applicant Vascular Pathways, Inc.

K number K112347

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FOZ 2011-08-30

INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1

Applicant B.Braun Melsungen AG

K number K111236

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FOZ 2011-07-19

BD INSYTE AUTOGUARD BC

Applicant Becton, Dickinson & CO

K number K110443

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FOZ 2011-01-06

BD NEXIVA CLOSED IV CATHETER SYSTEM

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K102520

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FOZ 2010-06-03

BD INTIMA II CLOSED IV CATHETER

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K100775

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FOZ 2010-05-06

SPECTRUM TURBO-JECT PICC SET

Applicant Cook Incorporated

K number K100974

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FOZ 2010-02-26

TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

Applicant Terumo Corp.

K number K100282

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FOZ 2009-12-17

SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX

Applicant Togo Medikit Co., Ltd.

K number K093546

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FOZ 2009-10-13

MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC

Applicant Edwards Lifesciences, LLC

K number K091709

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FOZ 2009-09-25

SNM FIRMGRIP

Applicant Flexicath , Ltd.

K number K092629

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FOZ 2009-08-07

I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT

Applicant Weihai Jierui Medical Products Co., Ltd.

K number K083429

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FOZ 2009-05-01

TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)

Applicant Terumo Corp.

K number K090973

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FOZ 2009-04-15

TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

Applicant Terumo Medical Corp.

K number K082997

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FOZ 2009-03-12

SUPERCATH 5

Applicant Togo Medikit Co., Ltd.

K number K081953

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FOZ 2009-03-10

NOVA SAFE SCALP VEIN BLOOD COLLECTION SET

Applicant U.S. Safety Syringes Co., Inc.

K number K090502

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FOZ 2009-02-05

NUOVOGUARD

Applicant U.S. Safety Syringes Co., Inc.

K number K090122

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FOZ 2008-12-04

NUOVOCATH

Applicant U.S. Safety Syringes Co., Inc.

K number K083454

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FOZ 2008-11-07

VANISHPOINT I.V. CATHETER

Applicant Retractable Technologies, Inc.

K number K081420

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FOZ 2008-10-16

FIRMGRIP

Applicant Flexicath , Ltd.

K number K080793

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FOZ 2008-09-17

SURSHIELD SAFETY I.V. CATHETER

Applicant Terumo Medical Corp.

K number K082362

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FOZ 2008-07-30

COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS

Applicant Cook, Inc.

K number K081113

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FOZ 2008-07-14

SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Applicant Cook, Inc.

K number K081690

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FOZ 2008-04-30

VANTAGECATH INTRAVASCULAR CATHETER

Applicant Advantage Medical Device

K number K073471

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FOZ 2008-04-11

ANGIOTECH CVC

Applicant Angiotech Pharmaceuticals, Inc.

K number K073520

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FOZ 2008-02-08

VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM

Applicant Vascular Pathways

K number K073241

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FOZ 2007-11-30

MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039

Applicant Vygon Corp.

K number K070705

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FOZ 2007-11-09

ADVANTIV SAFETY I.V. CATHETER

Applicant Smiths Medical Asd, Inc.

K number K072419

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FOZ 2007-10-16

SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,

Applicant Shinchang Medical Co., Ltd.

K number K071382

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FOZ 2007-08-30

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER

Applicant Arrow International, Inc.

K number K071538

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FOZ 2007-08-16

COMCASET-P SAFETY IV CATHETER

Applicant Pitango Medical, Ltd.

K number K070020

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FOZ 2007-07-31

ABLE CENTRAL VENOUS CATHETER

Applicant Foshan Nanhai Bai HE Medical Technology Co., Ltd.

K number K070451

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FOZ 2006-12-01

MEDICAN ALPHA

Applicant Eastern Medikit , Ltd.

K number K063469

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FOZ 2006-09-29

MULTICATH EXPERT

Applicant Vygon Corp.

K number K061250

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FOZ 2006-08-08

COMCASET SAFETY IV CATHETER

Applicant Pitango Medical, Ltd.

K number K062108

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FOZ 2006-04-14

SHERLOCK TIP LOCATION SYSTEM (TLS)

Applicant C.R. Bard, Inc.

K number K060341

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FOZ 2006-04-05

VYGON LEADER-FLEX

Applicant Vygon Corp.

K number K052564

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FOZ 2006-03-02

VYGON LATEX FREE BIONECTOR

Applicant Vygon Corp.

K number K052881

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FOZ 2006-02-17

SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM

Applicant Cook, Inc.

K number K060174

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FOZ 2006-01-19

CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER

Applicant Myco Medical Supplies, Inc.

K number K042504

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FOZ 2005-12-09

STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES

Applicant Excelsior Medical Corp.

K number K053120

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FOZ 2005-09-23

VANISHPOINT I.V. CATHETER

Applicant Retractable Technologies, Inc.

K number K051355

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FOZ 2005-09-09

I-PORT

Applicant Patton Medical Devices

K number K052389

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FOZ 2005-06-09

SUPERCATH Z3V

Applicant Togo Medikit Co., Ltd.

K number K050114

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FOZ 2005-02-04

EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER

Applicant Emmebi Srl

K number K043446

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FOZ 2004-12-03

BD ONECATH

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K042862

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FOZ 2004-08-12

SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING

Applicant Cook, Inc.

K number K033843

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FOZ 2004-07-22

PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES

Applicant Medix, Inc.

K number K041345

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FOZ 2004-05-03

FIBREX CATHETER PATENCY DEVICE

Applicant Medical Device Technologies, Inc.

K number K040427

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FOZ 2004-03-22

BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX

Applicant Bioteque Corp.

K number K032292

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FOZ 2004-02-27

NEXIVA CLOSED IV CATHETER SYSTEM

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K032843

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FOZ 2004-02-26

COOK FIVE LUMEN CENTRAL VENOUS CATHETER

Applicant Cook, Inc.

K number K032274

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FOZ 2004-01-29

BD CAREFLOW CENTRAL VENOUS CATHETER

Applicant Becton, Dickinson & CO

K number K033500

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FOZ 2004-01-14

MODIFICATION TO V-CATH POLY PICC

Applicant Hdc Corp.

K number K033853

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FOZ 2003-12-30

EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR

Applicant Edwards Lifesciences, LLC

K number K033250

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FOZ 2003-12-23

HEPARIN LOCK FLUSH SYRINGE

Applicant Am2 Pat, Inc.

K number K032417

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FOZ 2003-11-14

MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE

Applicant Nipro Medical Corp.

K number K032777

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FOZ 2003-10-29

AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE

Applicant Arrow Intl., Inc.

K number K032962

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FOZ 2003-08-18

JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET

Applicant Jms North America Corp.

K number K030479

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FOZ 2003-07-14

SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J

Applicant Sunder Biomedical Tech. Co., Ltd.

K number K024007

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FOZ 2003-05-30

SPECTRUM SILICONE CATHETER

Applicant Cook, Inc.

K number K021557

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FOZ 2003-05-06

PEDIATRIC CENTRAL VENOUS CATHETER KIT

Applicant B.Braun Medical, Inc.

K number K023253

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FOZ 2003-03-28

ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER

Applicant Ethicon Endo-Surgery, Inc.

K number K030571

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FOZ 2003-01-07

SPECATH CENTRAL VENOUS CATHETER KITS

Applicant Special Medical Co. , Ltd.

K number K021130

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FOZ 2002-10-18

NIPRO BIO-FLEX CATHETER

Applicant Nipro Medical Corp.

K number K022756

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FOZ 2002-09-20

SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S

Applicant Hdc Corp.

K number K022099

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FOZ 2002-08-28

INTROCAN SAFETY IV CATHETER

Applicant B.Braun Medical, Inc.

K number K020785

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FOZ 2002-07-01

TRIPLE LUMEN CENTRAL VENOUS CATHETER

Applicant Cook, Inc.

K number K013182

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FOZ 2002-04-17

TRULINE REINFORCED VALVED INFUSION CATHETER

Applicant Micro Therapeutics, Inc.

K number K021139

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FOZ 2002-01-28

SALINE IV FLUSH SYRINGE

Applicant Emt-Rx

K number K002142

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FOZ 2002-01-23

BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE

Applicant Bd

K number K011967

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FOZ 2001-12-31

MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE

Applicant Tyco Healthcare

K number K013556

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FOZ 2001-12-21

INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K013800

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FOZ 2001-12-03

NIPRO SAFELET CATH

Applicant Nipro Medical Corp.

K number K013287

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FOZ 2001-11-08

INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K013073

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FOZ 2001-08-28

TRULINE INFUSION CATHETERS

Applicant Micro Therapeutics, Inc.

K number K011937

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FOZ 2001-08-01

PROTECTIV ACUVANCE IV CATHETER SYSTEM

Applicant Ethicon Endo-Surgery, Inc.

K number K012128

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FOZ 2001-07-17

0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE

Applicant Bd

K number K011982

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FOZ 2001-06-27

KEYST0NE MEDICAL PICC CATHETER

Applicant Keystone Medical

K number K011860

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FOZ 2001-06-20

NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET

Applicant Nipro Medical Corp.

K number K011297

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FOZ 2001-06-20

JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G

Applicant Jms Co., Ltd.

K number K010410

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FOZ 2001-06-20

JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G

Applicant Jms Co., Ltd.

K number K010406

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FOZ 2001-05-21

VACUCATH I.V. CATHETER INTRODUCTER

Applicant Auto/Cath Vascular Access, Inc.

K number K003187

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FOZ 2001-03-21

0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K003553

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FOZ 2001-02-23

MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S

Applicant Medical Components, Inc.

K number K010021

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FOZ 2001-01-24

DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-

Applicant Cook, Inc.

K number K010034

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FOZ 2000-12-04

HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML

Applicant Baxter Healthcare Corp

K number K003245

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FOZ 2000-11-17

BIOSENSORS CENTRAL VENOUS CATHETER KITS

Applicant Sunscope Intl., Inc.

K number K002786

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FOZ 2000-10-19

THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD

Applicant Avitro, LLC

K number K001795

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FOZ 2000-10-19

0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE

Applicant Avitro, LLC

K number K000632

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FOZ 2000-09-07

ZORTRAN DETECTOR

Applicant Lucent Medical Systems

K number K000997

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FOZ 2000-07-27

MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE

Applicant Abbott Laboratories

K number K001616

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FOZ 2000-07-26

BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K002033

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FOZ 2000-06-13

VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING

Applicant Baxter Healthcare Corp

K number K992532

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FOZ 2000-06-12

MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL

Applicant Medefil, Inc.

K number K993518

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FOZ 2000-05-02

TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

Applicant Tfx Medical, Inc.

K number K000665

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FOZ 2000-04-20

STERILE WATER & STERILE 0.9% SODIUM CHLORIDE

Applicant Dumex Medical Surgical Products, Ltd.

K number K992732

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FOZ 2000-04-05

INSYTE CATHETER, INSYTE AUTOGUARD CATHETER

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K000235

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FOZ 2000-03-17

MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR

Applicant The Kendal Co.

K number K000087

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FOZ 2000-03-08

ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER

Applicant Arrow Intl., Inc.

K number K993691

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