FOZ · Class II · 21 CFR 880.5200

FDA Product Code FOZ: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Under FDA product code FOZ, short-term intravascular therapeutic catheters are cleared for the delivery of medications and fluids directly into the vascular system.

These catheters provide temporary vascular access for the administration of drugs, fluids, blood products, or parenteral nutrition over periods of days to weeks. They include peripheral and central venous catheters used across inpatient and outpatient settings.

FOZ devices are Class II medical devices, regulated under 21 CFR 880.5200 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Becton Dickinson Infusion Therapy Systems, Inc., Parke-Davis Co. and B.Braun Medical, Inc..

506
Total
506
Cleared
142d
Avg days
1976
Since
506 devices
169–192 of 506
Cleared Nov 19, 1990
CATH-FINDER(TM) CATHETER TRACKING SYSTEM
K904150
Pharmacia Deltec, Inc.
General Hospital · 73d
Cleared Oct 03, 1990
KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
K903732
Kendall Healthcare Products Co. Div.Of Tyco Health
General Hospital · 48d
Cleared Sep 12, 1990
SPLIT-SECOND INTRODUCER
K902527
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 99d
Cleared Aug 15, 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056
Abbott Laboratories
General Hospital · 224d
Cleared Aug 10, 1990
MULTICATH PLACEMENT KIT
K901640
Vygon Corp.
General Hospital · 123d
Cleared Jul 24, 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K900263
Arrow Intl., Inc.
General Hospital · 187d
Cleared Nov 01, 1989
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546
Critikon Company, LLC
General Hospital · 174d
Cleared Sep 08, 1989
PROLONG INTRAVASCULAR CATHETER
K893965
Baxter Healthcare Corp
General Hospital · 98d
Cleared Jun 23, 1989
TERUMO SURFLO(R) I.V. CATHETER
K891087
Terumo Medical Corp.
General Hospital · 114d
Cleared Apr 25, 1989
SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
K884325
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 193d
Cleared Feb 01, 1989
CATH-FINDER SYSTEM
K884701
Pharmacia Deltec, Inc.
General Hospital · 84d
Cleared Oct 04, 1988
VASCULON 2 INTRAVENOUS CANNULA
K883415
Ohmeda Medical
General Hospital · 50d
Cleared Aug 24, 1988
VIGGO INSUFLON
K881767
Ohmeda Medical
General Hospital · 121d
Cleared Jun 13, 1988
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215
Baxter Healthcare Corp
General Hospital · 83d
Cleared May 06, 1988
HR(TM) INTRAVASCULAR CATHETER
K881666
Icu Medical, Inc.
General Hospital · 18d
Cleared Jan 14, 1988
J&J SCALP VEIN INFUSION SETS
K875177
Critikon Company, LLC
General Hospital · 23d
Cleared Oct 20, 1987
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050
C.R. Bard, Inc.
General Hospital · 77d
Cleared Oct 15, 1987
CHURCHILL-CATH
K872585
Churchill Corp.
General Hospital · 106d
Cleared May 01, 1987
CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE
K870403
Burron Medical Products, Inc.
General Hospital · 88d
Cleared Feb 25, 1987
INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER
K864949
Quinton, Inc.
General Hospital · 82d
Cleared Dec 11, 1986
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
K862153
Arrow Intl., Inc.
General Hospital · 189d
Cleared Dec 04, 1986
INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT
K861725
Parke-Davis Co.
General Hospital · 212d
Cleared Jul 01, 1986
CAVAFIX, CENTRAL VENOUS CATHETER KIT
K861479
Burron Medical Products, Inc.
General Hospital · 70d
Cleared Jun 09, 1986
MULTILUMEN VIAPIC CENTRAL LINE CATHETER
K861510
Warner-Lambert Co.
General Hospital · 47d