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., Menlo Care, Inc. and Parke-Davis Co..

507
Total
507
Cleared
142d
Avg days
1976
Since
507 devices
313–336 of 507
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 08, 1989
LUMED EXPANDO-CATH, ACTIV
K884806
Luther Medical Products, Inc.
General Hospital · 83d
Cleared Feb 01, 1989
CATH-FINDER SYSTEM
K884701
Pharmacia Deltec, Inc.
General Hospital · 84d
Cleared Dec 05, 1988
LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES)
K883980
Menlo Care, Inc.
General Hospital · 75d
Cleared Nov 21, 1988
NEOSOFT UMBILICAL VESSEL CATHETER
K883866
Menlo Care, Inc.
General Hospital · 69d
Cleared Nov 01, 1988
MODIFIED LANDMARK VENOUS ACCESS DEVICE
K884259
Menlo Care, Inc.
General Hospital · 28d
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 20, 1988
LANDMARK(TM) VENOUS ACCESS DEVICE
K882242
Menlo Care, Inc.
General Hospital · 31d
Cleared Jun 13, 1988
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215
Baxter Healthcare Corp
General Hospital · 83d
Cleared May 11, 1988
TORAY ANTHRON P-U CATHETERS
K881236
Toray Industries (America), Inc.
General Hospital · 50d
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 Dec 29, 1987
DESERET SPLITTABLE CATHETER
K874582
Deseret Medical, Inc.
General Hospital · 50d
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 Jun 17, 1987
SAFESIDE(TM) LUMED
K871546
Luther Medical Products, Inc.
General Hospital · 58d
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 Dec 04, 1986
SUPERCATH I.V. CATHETER
K864038
Togo Medikit Co., Ltd.
General Hospital · 49d
Cleared Aug 14, 1986
COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.
K862130
Menlo Care, Inc.
General Hospital · 71d