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
Aug 20, 1980
L-CATH INTRAVENOUS PLACEMENT UNIT
Luther Medical Products, Inc.
General Hospital
43d
Cleared
Aug 13, 1980
ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
G.D. Searle and Co.
General Hospital
58d
Cleared
May 08, 1980
INJECTION SITE, CODE NO. 3100
Quest Medical, Inc.
General Hospital
30d
Cleared
Apr 08, 1980
MEDICAL COMPONENTS IV CATHETER
Medical Components, Inc.
General Hospital
32d
Cleared
Oct 02, 1979
JELCO WINGED INTRAVASCULAR CATHETER
Jelco Laboratories
General Hospital
7d
Cleared
Jul 03, 1979
SILASTIC INTRAVENOUS CATHETER UNIT
Dow Corning Corp. Healthcare Industries Materials
General Hospital
50d
Cleared
Jun 27, 1979
CATHETER METAL HUB/RADIOPAQUE
Jelco Laboratories
General Hospital
36d
Cleared
Jun 15, 1979
WHOLEY OCCLUSION BALLOON CATHETER
Cook, Inc.
General Hospital
598d
Cleared
Jun 11, 1979
CATHETER METAL HUB/NONRADIOPAQUE
Jelco Laboratories
General Hospital
20d
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
Oct 13, 1977
IV CATHETER HUB
Jelco Laboratories
General Hospital
79d
Cleared
May 26, 1977
CATHETERS, OVER-THE-NEEDLE
Cutter Laboratories, Inc.
General Hospital
31d
Cleared
May 10, 1977
CANNULA, INTRAVENOUS, TEFLON
Sherwood Medical Industries
General Hospital
54d
Cleared
Apr 29, 1977
CANNULA, INTRAVENOUS, HEPARINIZED
Sherwood Medical Industries
General Hospital
43d
Cleared
Mar 16, 1977
CATHETER-THRU-NEEDLE DEVICE
Abbott Laboratories
General Hospital
13d
Cleared
Aug 11, 1976
KIT, CATHETER
Jelco Laboratories
General Hospital
16d
Cleared
Jul 20, 1976
CATHETER, INTRAVASCULAR (MEDICUT T)
Sherwood Medical Industries
General Hospital
20d