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
Cleared
Jun 23, 1989
TERUMO SURFLO(R) I.V. CATHETER
Terumo Medical Corp.
General Hospital
114d
Cleared
Apr 25, 1989
SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
193d
Cleared
Feb 08, 1989
LUMED EXPANDO-CATH, ACTIV
Luther Medical Products, Inc.
General Hospital
83d
Cleared
Feb 01, 1989
CATH-FINDER SYSTEM
Pharmacia Deltec, Inc.
General Hospital
84d
Cleared
Dec 05, 1988
LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES)
Menlo Care, Inc.
General Hospital
75d
Cleared
Nov 21, 1988
NEOSOFT UMBILICAL VESSEL CATHETER
Menlo Care, Inc.
General Hospital
69d
Cleared
Nov 01, 1988
MODIFIED LANDMARK VENOUS ACCESS DEVICE
Menlo Care, Inc.
General Hospital
28d
Cleared
Oct 04, 1988
VASCULON 2 INTRAVENOUS CANNULA
Ohmeda Medical
General Hospital
50d
Cleared
Aug 24, 1988
VIGGO INSUFLON
Ohmeda Medical
General Hospital
121d
Cleared
Jun 20, 1988
LANDMARK(TM) VENOUS ACCESS DEVICE
Menlo Care, Inc.
General Hospital
31d
Cleared
Jun 13, 1988
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
Baxter Healthcare Corp
General Hospital
83d
Cleared
May 11, 1988
TORAY ANTHRON P-U CATHETERS
Toray Industries (America), Inc.
General Hospital
50d
Cleared
May 06, 1988
HR(TM) INTRAVASCULAR CATHETER
Icu Medical, Inc.
General Hospital
18d
Cleared
Jan 14, 1988
J&J SCALP VEIN INFUSION SETS
Critikon Company, LLC
General Hospital
23d
Cleared
Dec 29, 1987
DESERET SPLITTABLE CATHETER
Deseret Medical, Inc.
General Hospital
50d
Cleared
Oct 20, 1987
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
C.R. Bard, Inc.
General Hospital
77d
Cleared
Oct 15, 1987
CHURCHILL-CATH
Churchill Corp.
General Hospital
106d
Cleared
Jun 17, 1987
SAFESIDE(TM) LUMED
Luther Medical Products, Inc.
General Hospital
58d
Cleared
May 01, 1987
CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE
Burron Medical Products, Inc.
General Hospital
88d
Cleared
Feb 25, 1987
INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER
Quinton, Inc.
General Hospital
82d
Cleared
Dec 11, 1986
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
Arrow Intl., Inc.
General Hospital
189d
Cleared
Dec 04, 1986
INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT
Parke-Davis Co.
General Hospital
212d
Cleared
Dec 04, 1986
SUPERCATH I.V. CATHETER
Togo Medikit Co., Ltd.
General Hospital
49d
Cleared
Aug 14, 1986
COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.
Menlo Care, Inc.
General Hospital
71d