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
Cleared
Nov 19, 1990
CATH-FINDER(TM) CATHETER TRACKING SYSTEM
Pharmacia Deltec, Inc.
General Hospital
73d
Cleared
Oct 03, 1990
KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
Kendall Healthcare Products Co. Div.Of Tyco Health
General Hospital
48d
Cleared
Sep 12, 1990
SPLIT-SECOND INTRODUCER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
99d
Cleared
Aug 15, 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
Abbott Laboratories
General Hospital
224d
Cleared
Aug 10, 1990
MULTICATH PLACEMENT KIT
Vygon Corp.
General Hospital
123d
Cleared
Jul 24, 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
Arrow Intl., Inc.
General Hospital
187d
Cleared
Nov 01, 1989
OPTICALLY CLEAR RADIOPAQUE CATHETER
Critikon Company, LLC
General Hospital
174d
Cleared
Sep 08, 1989
PROLONG INTRAVASCULAR CATHETER
Baxter Healthcare Corp
General Hospital
98d
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 01, 1989
CATH-FINDER SYSTEM
Pharmacia Deltec, Inc.
General Hospital
84d
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 13, 1988
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
Baxter Healthcare Corp
General Hospital
83d
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
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
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
Jul 01, 1986
CAVAFIX, CENTRAL VENOUS CATHETER KIT
Burron Medical Products, Inc.
General Hospital
70d
Cleared
Jun 09, 1986
MULTILUMEN VIAPIC CENTRAL LINE CATHETER
Warner-Lambert Co.
General Hospital
47d