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., Bd Becton Dickinson Vacutainer Systems Preanalytic and C.R. Bard, Inc..

504
Total
504
Cleared
142d
Avg days
1976
Since
504 devices
73–96 of 504
Cleared Dec 04, 2000
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
K003245
Baxter Healthcare Corp
General Hospital · 48d
Cleared Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K001616
Abbott Laboratories
General Hospital · 63d
Cleared Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
K992532
Baxter Healthcare Corp
General Hospital · 320d
Cleared Oct 07, 1999
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K984590
Baxter Healthcare Corp
General Hospital · 283d
Cleared Apr 09, 1999
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
K984059
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 147d
Cleared Sep 14, 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
K980566
Boston Scientific Corp
General Hospital · 213d
Cleared Feb 10, 1997
CVP POLYURETHANE CATHETER
K961552
Abbott Laboratories
General Hospital · 294d
Cleared Jun 28, 1996
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
K953805
Abbott Laboratories
General Hospital · 325d
Cleared Dec 12, 1994
PRN ADAPTER
K933467
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 514d
Cleared Sep 28, 1992
SAFE-DWELL PLUS CENTRAL VENOUS CATHETER
K921270
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 195d
Cleared Apr 06, 1992
E-Z SET/MINICATH INFUSION SETS
K920635
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 54d
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 Sep 08, 1989
PROLONG INTRAVASCULAR CATHETER
K893965
Baxter Healthcare Corp
General Hospital · 98d
Cleared Apr 25, 1989
SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
K884325
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 193d
Cleared Jun 13, 1988
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215
Baxter Healthcare Corp
General Hospital · 83d
Cleared Oct 20, 1987
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050
C.R. Bard, Inc.
General Hospital · 77d
Cleared Apr 07, 1986
POLYCATH-H CATHETER
K854308
Abbott Laboratories
General Hospital · 164d
Cleared Feb 04, 1984
INJECTION CAP
K834480
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 46d
Cleared Mar 31, 1983
WINGED CATHETER
K830765
Abbott Laboratories
General Hospital · 21d
Cleared Nov 06, 1981
B-D HEPARINIZED LONGDWEL I.V. CATHETER
K812137
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 101d
Cleared Mar 27, 1978
I.V. START KIT
K780350
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 24d
Cleared Feb 21, 1978
NEEDLE CONNECTING SET, BLUNT
K780105
Abbott Laboratories
General Hospital · 32d
Cleared Mar 16, 1977
CATHETER-THRU-NEEDLE DEVICE
K770403
Abbott Laboratories
General Hospital · 13d