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
Sep 09, 1997
VYGON UMBILICAL CATHETHER INSERTION TRAY
Vygon Corp.
General Hospital
390d
Cleared
Aug 21, 1997
ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
Arrow Intl., Inc.
General Hospital
416d
Cleared
Feb 10, 1997
CVP POLYURETHANE CATHETER
Abbott Laboratories
General Hospital
294d
Cleared
Dec 23, 1996
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM
Johnson & Johnson Medical, Inc.
General Hospital
196d
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
Feb 08, 1996
ABRM CATHETER
Cook, Inc.
General Hospital
393d
Cleared
Jan 23, 1996
MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER
Micro Therapeutics, Inc.
General Hospital
190d
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
Sep 21, 1995
STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
Trinity Laboratories, Inc.
General Hospital
142d
Cleared
Jun 26, 1995
BIONECTOR
Vygon Corp.
General Hospital
447d
Cleared
Mar 22, 1995
MAHURKAR DUAL LUMEN CATHETER
Quinton, Inc.
General Hospital
253d
Cleared
Dec 12, 1994
PRN ADAPTER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
514d
Cleared
Oct 14, 1994
CUFF-CATH
Ohmeda Medical
General Hospital
357d
Cleared
Oct 14, 1994
MICRO THERAPEUTICS INFUSION CATHETER
Micro Therapeutics, Inc.
General Hospital
242d
Cleared
May 05, 1994
CATH-FINDER
Pharmacia Deltec, Inc.
General Hospital
429d
Cleared
Mar 21, 1994
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
Pharmacia Deltec, Inc.
General Hospital
445d
Cleared
Dec 14, 1993
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
Critikon Company, LLC
General Hospital
208d
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
Apr 29, 1991
INJECTION CAPS
Akcess Medical Products, Inc.
General Hospital
77d
Cleared
Feb 11, 1991
DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL
Davol, Inc.
General Hospital
129d