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 1994-02-04

BULLETT PERIPHERAL INFUSION CATHETER

Applicant Cardio-Dynamics, Inc.

K number K931027

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FOZ 1994-02-03

.9% NORMAL SALINE TUBE/STERILE WATER TUBE

Applicant Gam-Med Packaging Corp.

K number K926405

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FOZ 1993-12-14

CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH

Applicant Critikon Company, LLC

K number K933050

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FOZ 1993-09-22

INTIMA POINT GUARD INTRAVASCULAR CATHETER

Applicant Becton Dickinson Vascular Access, Inc.

K number K923702

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FOZ 1993-08-31

CYBILNATE(R) UMBILICAL CATHETER

Applicant Cyex Medical Technologies, Inc.

K number K926097

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FOZ 1993-07-13

INTERMITTENT INJECTION SITE

Applicant Kawasumi Laboratories Co., Ltd.

K number K923323

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FOZ 1993-05-21

L-CATH PEEL-AWAY CATHETER SYSTEM

Applicant Luther Medical Products, Inc.

K number K924968

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FOZ 1993-05-20

PERIPHERAL INTERVENOUS CATHETER

Applicant Medical Profiles, Inc.

K number K914378

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FOZ 1993-03-26

BIO-MATE PIC CATHETER

Applicant Medevice, Inc.

K number K920638

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FOZ 1993-01-29

QUIK FLOW

Applicant California Medical Equipment, Inc.

K number K921955

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FOZ 1993-01-29

HOLE PUNCH

Applicant American Biomaterials Corp.

K number K915824

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FOZ 1992-10-13

SAFEDWEL(R) CENTRAL VENOUS CATHETER

Applicant Becton Dickinson Vascular Access, Inc.

K number K914528

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FOZ 1992-09-28

SAFE-DWELL PLUS CENTRAL VENOUS CATHETER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K921270

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FOZ 1992-08-14

SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT

Applicant Menlo Care, Inc.

K number K920828

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FOZ 1992-05-08

DESERET(R) FLOW RESTRICTION VALVE

Applicant Becton Dickinson Vascular Access, Inc.

K number K914180

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FOZ 1992-04-06

E-Z SET/MINICATH INFUSION SETS

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K920635

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FOZ 1992-03-26

VERSACATH SELECTALUMEN INNER CATHETER

Applicant Menlo Care, Inc.

K number K920133

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FOZ 1992-03-26

VERSACATH MAINLINE CENTRAL VENOUS CATHETER

Applicant Menlo Care, Inc.

K number K920128

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FOZ 1992-03-26

LANDMARK MIDLINE CATHETER

Applicant Menlo Care, Inc.

K number K920028

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FOZ 1992-02-11

I.V.IRRIGATION POLE

Applicant American Medical Mfg., Inc.

K number K915065

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FOZ 1992-01-02

LANDMARK ADD-A-LUMEN CATHETER KIT

Applicant Menlo Care, Inc.

K number K912358

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FOZ 1991-12-11

LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM

Applicant Menlo Care, Inc.

K number K912165

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FOZ 1991-10-28

FLEX-IV

Applicant Medway

K number K911251

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FOZ 1991-10-23

CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY

Applicant Medical Device Inspection Co., Inc.

K number K912158

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FOZ 1991-10-02

ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE

Applicant Mbo Laboratories, Inc.

K number K912563

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FOZ 1991-08-12

BRAIDED HIGH PRESSURE CATHETER CONNECTOR

Applicant The R Group

K number K905415

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FOZ 1991-06-03

VERSACATH(TM) MULTILUMEN SYSTEM

Applicant Menlo Care, Inc.

K number K910566

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FOZ 1991-06-03

VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY

Applicant Menlo Care, Inc.

K number K910565

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FOZ 1991-05-06

VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY

Applicant Menlo Care, Inc.

K number K910564

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FOZ 1991-04-29

INJECTION CAPS

Applicant Akcess Medical Products, Inc.

K number K910572

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FOZ 1991-03-21

LANDMARK VENOUS ACCESS DEVICE

Applicant Menlo Care, Inc.

K number K910799

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FOZ 1991-02-11

DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL

Applicant Davol, Inc.

K number K904558

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FOZ 1991-01-22

GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION

Applicant Angiosystems, Inc.

K number K905463

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FOZ 1990-12-18

DIGITCARE I.V. START KIT

Applicant Digitcare Corp.

K number K905009

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FOZ 1990-12-14

SAFE SYTE I.V. CATHETER PLACEMENT UNIT

Applicant Deseret Medical, Inc.

K number K904648

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FOZ 1990-12-13

SODIUM CHLORIDE SOLUTION

Applicant Superior Healthcare Group, Inc.

K number K903347

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FOZ 1990-11-19

CATH-FINDER(TM) CATHETER TRACKING SYSTEM

Applicant Pharmacia Deltec, Inc.

K number K904150

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FOZ 1990-11-13

CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS

Applicant J.J. Skinner, Inc.

K number K903545

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FOZ 1990-11-08

VIALON OBTURATOR

Applicant Deseret Medical, Inc.

K number K904121

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FOZ 1990-10-19

MODIFIED INTRAVENOUS CATHETER

Applicant Safeguard Needle Co.

K number K896813

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FOZ 1990-10-04

INSYTE-A ARTERIAL CATHETERIZATION UNIT

Applicant Deseret Medical, Inc.

K number K904122

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FOZ 1990-10-03

KENDALL SAFETRAK(TM) HIGH FLOW CATHETER

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K903732

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FOZ 1990-09-19

CENTRAL VENOUS ACCESS CATHETER

Applicant Cardiopulmonics, Inc.

K number K901701

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FOZ 1990-09-12

SPLIT-SECOND INTRODUCER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K902527

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FOZ 1990-09-12

VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER

Applicant Vas-Cath, Inc.

K number K895597

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FOZ 1990-09-07

SHARGHP INTRAVENOUS CATHETER

Applicant Shargh Pharmaceutical Co., Inc.

K number K895812

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FOZ 1990-08-22

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

Applicant Navion Biomedical Corp.

K number K901263

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FOZ 1990-08-15

CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE

Applicant Abbott Laboratories

K number K900056

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FOZ 1990-08-10

MULTICATH PLACEMENT KIT

Applicant Vygon Corp.

K number K901640

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FOZ 1990-08-01

PERCUTANEOUS INTRODUCER KIT

Applicant Device Labs, Inc.

K number K902135

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FOZ 1990-07-24

ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER

Applicant Arrow Intl., Inc.

K number K900263

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FOZ 1990-07-02

GESCO DUAL LUMEN PER-Q-CATH-DL

Applicant Gesco Intl., Inc.

K number K895942

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FOZ 1990-06-18

DESERET OPTIMA INTRAVASCULAR CATHETER

Applicant Deseret Medical, Inc.

K number K900116

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FOZ 1990-04-09

DESERET INTRAVASCULAR CATHETER

Applicant Deseret Medical, Inc.

K number K895734

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FOZ 1990-02-16

EXEL SAFELET CATHETER

Applicant Exel Intl.

K number K895768

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FOZ 1989-12-27

STREAMLINE VASCULAR ACCESS DEVICE

Applicant Menlo Care, Inc.

K number K896774

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FOZ 1989-12-15

CATHETER CARE KITS

Applicant L H M Ent., Inc.

K number K894611

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FOZ 1989-11-24

ANTI-THROMBOGENIC COATING FOR CATHETERS

Applicant Burron Medical, Inc.

K number K895191

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FOZ 1989-11-01

OPTICALLY CLEAR RADIOPAQUE CATHETER

Applicant Critikon Company, LLC

K number K893546

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FOZ 1989-10-25

NIPRO SAFELET CATH

Applicant Pharma-Plast USA, Inc.

K number K894371

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FOZ 1989-09-08

PROLONG INTRAVASCULAR CATHETER

Applicant Baxter Healthcare Corp

K number K893965

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FOZ 1989-08-01

PROCEDURE READY TRAYS

Applicant Professional Medical Services

K number K884577

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FOZ 1989-07-14

TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE

Applicant United Medical Systems, Inc.

K number K893003

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FOZ 1989-06-23

TERUMO SURFLO(R) I.V. CATHETER

Applicant Terumo Medical Corp.

K number K891087

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FOZ 1989-04-25

SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K884325

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FOZ 1989-04-21

ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT

Applicant Medical Safety Products, Inc.

K number K890751

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FOZ 1989-03-29

VITAACCESS CATHETER INTRODUCER KIT

Applicant Vitaphore Corp.

K number K890435

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FOZ 1989-02-08

LUMED EXPANDO-CATH, ACTIV

Applicant Luther Medical Products, Inc.

K number K884806

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FOZ 1989-02-01

CATH-FINDER SYSTEM

Applicant Pharmacia Deltec, Inc.

K number K884701

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FOZ 1988-12-05

LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES)

Applicant Menlo Care, Inc.

K number K883980

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FOZ 1988-11-21

NEOSOFT UMBILICAL VESSEL CATHETER

Applicant Menlo Care, Inc.

K number K883866

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FOZ 1988-11-01

MODIFIED LANDMARK VENOUS ACCESS DEVICE

Applicant Menlo Care, Inc.

K number K884259

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FOZ 1988-10-04

VASCULON 2 INTRAVENOUS CANNULA

Applicant Ohmeda Medical

K number K883415

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FOZ 1988-08-24

VIGGO INSUFLON

Applicant Ohmeda Medical

K number K881767

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FOZ 1988-08-04

CATHETER, INTRAVASCULAR

Applicant Primrose Medical, Inc.

K number K881976

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FOZ 1988-06-20

LANDMARK(TM) VENOUS ACCESS DEVICE

Applicant Menlo Care, Inc.

K number K882242

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FOZ 1988-06-13

CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH

Applicant Baxter Healthcare Corp

K number K881215

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FOZ 1988-05-11

TORAY ANTHRON P-U CATHETERS

Applicant Toray Industries (America), Inc.

K number K881236

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FOZ 1988-05-06

HR(TM) INTRAVASCULAR CATHETER

Applicant Icu Medical, Inc.

K number K881666

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FOZ 1988-04-19

SAFECATH

Applicant Phase Medical Systems, Inc.

K number K880260

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FOZ 1988-03-24

VITAACCESS (TM) CATHETER INTRODUCER SYSTEM

Applicant Vitaphore Corp.

K number K872998

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FOZ 1988-03-08

O.P.C. INTRAVASCULAR CATHETER

Applicant Taut, Inc.

K number K875082

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FOZ 1988-01-14

J&J SCALP VEIN INFUSION SETS

Applicant Critikon Company, LLC

K number K875177

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FOZ 1987-12-29

DESERET SPLITTABLE CATHETER

Applicant Deseret Medical, Inc.

K number K874582

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FOZ 1987-10-20

VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF

Applicant C.R. Bard, Inc.

K number K873050

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FOZ 1987-10-15

CHURCHILL-CATH

Applicant Churchill Corp.

K number K872585

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FOZ 1987-06-17

SAFESIDE(TM) LUMED

Applicant Luther Medical Products, Inc.

K number K871546

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FOZ 1987-05-01

CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE

Applicant Burron Medical Products, Inc.

K number K870403

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FOZ 1987-02-25

INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER

Applicant Quinton, Inc.

K number K864949

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FOZ 1986-12-11

ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE

Applicant Arrow Intl., Inc.

K number K862153

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FOZ 1986-12-04

SUPERCATH I.V. CATHETER

Applicant Togo Medikit Co., Ltd.

K number K864038

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FOZ 1986-12-04

INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT

Applicant Parke-Davis Co.

K number K861725

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FOZ 1986-08-14

COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.

Applicant Menlo Care, Inc.

K number K862130

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FOZ 1986-07-31

BT CATH (INTRAVASCULAR CATHETER)

Applicant Baron Technologies, Inc.

K number K862480

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FOZ 1986-07-01

CAVAFIX, CENTRAL VENOUS CATHETER KIT

Applicant Burron Medical Products, Inc.

K number K861479

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FOZ 1986-06-18

ANTHRON CATHETERS & SETS

Applicant Toray Industries (America), Inc.

K number K861117

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FOZ 1986-06-09

MULTILUMEN VIAPIC CENTRAL LINE CATHETER

Applicant Warner-Lambert Co.

K number K861510

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FOZ 1986-05-06

STREAM LINE* I.V. CATHETER PLACEMENT UNIT

Applicant Menlo Care, Inc.

K number K860474

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FOZ 1986-05-01

FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI

Applicant Foran Industries, Inc.

K number K853988

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FOZ 1986-04-22

ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS

Applicant Acme United Corp.

K number K861015

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