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
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
Oct 06, 1994
VITAFLON PLUS/VASCULON
Hogan & Hartson
General Hospital
197d
Cleared
May 12, 1994
SAFE-PICC CATHETER
Menlo Care, Inc.
General Hospital
492d
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
Mar 07, 1994
PICC INSERTION TRAY
Clinipad Corp.
General Hospital
335d
Cleared
Feb 22, 1994
I.V. START KIT
Carapace, Inc.
General Hospital
321d
Cleared
Feb 17, 1994
I.V. START KIT
Clinipad Corp.
General Hospital
295d
Cleared
Dec 14, 1993
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
Critikon Company, LLC
General Hospital
208d
Cleared
Sep 22, 1993
INTIMA POINT GUARD INTRAVASCULAR CATHETER
Becton Dickinson Vascular Access, Inc.
General Hospital
425d
Cleared
Jul 13, 1993
INTERMITTENT INJECTION SITE
Kawasumi Laboratories Co., Ltd.
General Hospital
371d
Cleared
May 21, 1993
L-CATH PEEL-AWAY CATHETER SYSTEM
Luther Medical Products, Inc.
General Hospital
233d
Cleared
Oct 13, 1992
SAFEDWEL(R) CENTRAL VENOUS CATHETER
Becton Dickinson Vascular Access, Inc.
General Hospital
370d
Cleared
Sep 28, 1992
SAFE-DWELL PLUS CENTRAL VENOUS CATHETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
195d
Cleared
Aug 14, 1992
SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT
Menlo Care, Inc.
General Hospital
172d
Cleared
May 08, 1992
DESERET(R) FLOW RESTRICTION VALVE
Becton Dickinson Vascular Access, Inc.
General Hospital
233d
Cleared
Apr 06, 1992
E-Z SET/MINICATH INFUSION SETS
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
54d
Cleared
Mar 26, 1992
LANDMARK MIDLINE CATHETER
Menlo Care, Inc.
General Hospital
83d
Cleared
Mar 26, 1992
VERSACATH MAINLINE CENTRAL VENOUS CATHETER
Menlo Care, Inc.
General Hospital
73d
Cleared
Mar 26, 1992
VERSACATH SELECTALUMEN INNER CATHETER
Menlo Care, Inc.
General Hospital
73d
Cleared
Jan 02, 1992
LANDMARK ADD-A-LUMEN CATHETER KIT
Menlo Care, Inc.
General Hospital
219d
Cleared
Dec 11, 1991
LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM
Menlo Care, Inc.
General Hospital
209d
Cleared
Oct 23, 1991
CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY
Medical Device Inspection Co., Inc.
General Hospital
160d