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., Menlo Care, Inc. and Parke-Davis Co..

507
Total
507
Cleared
142d
Avg days
1976
Since
507 devices
265–288 of 507
Cleared Oct 14, 1994
CUFF-CATH
K935090
Ohmeda Medical
General Hospital · 357d
Cleared Oct 14, 1994
MICRO THERAPEUTICS INFUSION CATHETER
K940634
Micro Therapeutics, Inc.
General Hospital · 242d
Cleared Oct 06, 1994
VITAFLON PLUS/VASCULON
K941417
Hogan & Hartson
General Hospital · 197d
Cleared May 12, 1994
SAFE-PICC CATHETER
K930048
Menlo Care, Inc.
General Hospital · 492d
Cleared May 05, 1994
CATH-FINDER
K931073
Pharmacia Deltec, Inc.
General Hospital · 429d
Cleared Mar 21, 1994
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K926544
Pharmacia Deltec, Inc.
General Hospital · 445d
Cleared Mar 07, 1994
PICC INSERTION TRAY
K931668
Clinipad Corp.
General Hospital · 335d
Cleared Feb 22, 1994
I.V. START KIT
K931729
Carapace, Inc.
General Hospital · 321d
Cleared Feb 17, 1994
I.V. START KIT
K932071
Clinipad Corp.
General Hospital · 295d
Cleared Dec 14, 1993
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
K933050
Critikon Company, LLC
General Hospital · 208d
Cleared Sep 22, 1993
INTIMA POINT GUARD INTRAVASCULAR CATHETER
K923702
Becton Dickinson Vascular Access, Inc.
General Hospital · 425d
Cleared Jul 13, 1993
INTERMITTENT INJECTION SITE
K923323
Kawasumi Laboratories Co., Ltd.
General Hospital · 371d
Cleared May 21, 1993
L-CATH PEEL-AWAY CATHETER SYSTEM
K924968
Luther Medical Products, Inc.
General Hospital · 233d
Cleared Oct 13, 1992
SAFEDWEL(R) CENTRAL VENOUS CATHETER
K914528
Becton Dickinson Vascular Access, Inc.
General Hospital · 370d
Cleared Sep 28, 1992
SAFE-DWELL PLUS CENTRAL VENOUS CATHETER
K921270
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 195d
Cleared Aug 14, 1992
SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT
K920828
Menlo Care, Inc.
General Hospital · 172d
Cleared May 08, 1992
DESERET(R) FLOW RESTRICTION VALVE
K914180
Becton Dickinson Vascular Access, Inc.
General Hospital · 233d
Cleared Apr 06, 1992
E-Z SET/MINICATH INFUSION SETS
K920635
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 54d
Cleared Mar 26, 1992
LANDMARK MIDLINE CATHETER
K920028
Menlo Care, Inc.
General Hospital · 83d
Cleared Mar 26, 1992
VERSACATH MAINLINE CENTRAL VENOUS CATHETER
K920128
Menlo Care, Inc.
General Hospital · 73d
Cleared Mar 26, 1992
VERSACATH SELECTALUMEN INNER CATHETER
K920133
Menlo Care, Inc.
General Hospital · 73d
Cleared Jan 02, 1992
LANDMARK ADD-A-LUMEN CATHETER KIT
K912358
Menlo Care, Inc.
General Hospital · 219d
Cleared Dec 11, 1991
LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM
K912165
Menlo Care, Inc.
General Hospital · 209d
Cleared Oct 23, 1991
CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY
K912158
Medical Device Inspection Co., Inc.
General Hospital · 160d