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..
508
Total
508
Cleared
143d
Avg days
1976
Since
508 devices
Cleared
Nov 06, 1996
NEO-CARE CATHETERIZATION TRAY
Klein-Baker Medical, Inc.
General Hospital
41d
Cleared
Oct 25, 1996
EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
Excelsior Medical Corp.
General Hospital
88d
Cleared
Jul 25, 1996
MEDCOMP P-CATH
Medcomp
General Hospital
365d
Cleared
Jun 28, 1996
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
Abbott Laboratories
General Hospital
325d
Cleared
May 09, 1996
VYGON LIFEVAC MID-LINE TRAY
Vygon Corp.
General Hospital
283d
Cleared
Apr 04, 1996
MIDMARK MIDLINE CATHETER
Menlo Care, Inc.
General Hospital
363d
Cleared
Mar 28, 1996
SOLOPICC 24 (60CM) 20GA CATHETER
Douglas Medical Products Corp.
General Hospital
188d
Cleared
Mar 28, 1996
NIPRO SAFELET CATH
Nissho Corp.
General Hospital
84d
Cleared
Mar 25, 1996
MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER
Baxter Edwards
General Hospital
90d
Cleared
Feb 13, 1996
MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM
MDC Research , Ltd.
General Hospital
42d
Cleared
Feb 08, 1996
ABRM CATHETER
Cook, Inc.
General Hospital
393d
Cleared
Jan 24, 1996
STERILE WATER O.9% STERILE SALINE
Lockett Medical Corp.
General Hospital
100d
Cleared
Jan 23, 1996
MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER
Micro Therapeutics, Inc.
General Hospital
190d
Cleared
Jan 04, 1996
NIPRO SCALP VEIN SET (DISPOSABL PSV SET)
Nissho Corp.
General Hospital
59d
Cleared
Dec 13, 1995
VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE
Vital Signs, Inc.
General Hospital
187d
Cleared
Dec 13, 1995
VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE
Vital Signs, Inc.
General Hospital
161d
Cleared
Nov 03, 1995
COMFORT-Q SUBCUTANEOUS INJECTION SETS
B. Braun of America, Inc.
General Hospital
319d
Cleared
Sep 21, 1995
STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
Trinity Laboratories, Inc.
General Hospital
142d
Cleared
Sep 01, 1995
WALLACE IV CANNULA
Smiths Industries Medical Systems, Inc.
General Hospital
806d
Cleared
Sep 01, 1995
WALLACE Y-CAN
Smiths Industries Medical Systems, Inc.
General Hospital
806d
Cleared
Jul 31, 1995
PICC LINE KIT
Medi-Flex Hospital Products, Inc.
General Hospital
77d
Cleared
Jul 31, 1995
ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER
Becton Dickinson Vascular Access, Inc.
General Hospital
45d
Cleared
Jul 31, 1995
ANGIOCATH & INSYTE AUTOGUARD CATHETERS
Becton Dickinson Vascular Access, Inc.
General Hospital
39d
Cleared
Jun 26, 1995
BIONECTOR
Vygon Corp.
General Hospital
447d