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., Bd Becton Dickinson Vacutainer Systems Preanalytic and C.R. Bard, Inc..
504
Total
504
Cleared
142d
Avg days
1976
Since
504 devices
Cleared
Dec 04, 2000
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
Baxter Healthcare Corp
General Hospital
48d
Cleared
Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
Abbott Laboratories
General Hospital
63d
Cleared
Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
Baxter Healthcare Corp
General Hospital
320d
Cleared
Oct 07, 1999
0.9% SODIUM CHLORIDE FLUSH SYRINGE
Baxter Healthcare Corp
General Hospital
283d
Cleared
Apr 09, 1999
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
147d
Cleared
Sep 14, 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
Boston Scientific Corp
General Hospital
213d
Cleared
Feb 10, 1997
CVP POLYURETHANE CATHETER
Abbott Laboratories
General Hospital
294d
Cleared
Jun 28, 1996
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
Abbott Laboratories
General Hospital
325d
Cleared
Dec 12, 1994
PRN ADAPTER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
514d
Cleared
Sep 28, 1992
SAFE-DWELL PLUS CENTRAL VENOUS CATHETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
195d
Cleared
Apr 06, 1992
E-Z SET/MINICATH INFUSION SETS
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
54d
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
Sep 08, 1989
PROLONG INTRAVASCULAR CATHETER
Baxter Healthcare Corp
General Hospital
98d
Cleared
Apr 25, 1989
SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
193d
Cleared
Jun 13, 1988
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
Baxter Healthcare Corp
General Hospital
83d
Cleared
Oct 20, 1987
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
C.R. Bard, Inc.
General Hospital
77d
Cleared
Apr 07, 1986
POLYCATH-H CATHETER
Abbott Laboratories
General Hospital
164d
Cleared
Feb 04, 1984
INJECTION CAP
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
46d
Cleared
Mar 31, 1983
WINGED CATHETER
Abbott Laboratories
General Hospital
21d
Cleared
Nov 06, 1981
B-D HEPARINIZED LONGDWEL I.V. CATHETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
101d
Cleared
Mar 27, 1978
I.V. START KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
24d
Cleared
Feb 21, 1978
NEEDLE CONNECTING SET, BLUNT
Abbott Laboratories
General Hospital
32d
Cleared
Mar 16, 1977
CATHETER-THRU-NEEDLE DEVICE
Abbott Laboratories
General Hospital
13d