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., Parke-Davis Co. and B.Braun Medical, Inc..

506
Total
506
Cleared
142d
Avg days
1976
Since
506 devices
145–168 of 506
Cleared Sep 09, 1997
VYGON UMBILICAL CATHETHER INSERTION TRAY
K963196
Vygon Corp.
General Hospital · 390d
Cleared Aug 21, 1997
ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
K962577
Arrow Intl., Inc.
General Hospital · 416d
Cleared Feb 10, 1997
CVP POLYURETHANE CATHETER
K961552
Abbott Laboratories
General Hospital · 294d
Cleared Dec 23, 1996
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM
K962226
Johnson & Johnson Medical, Inc.
General Hospital · 196d
Cleared Jul 25, 1996
MEDCOMP P-CATH
K953811
Medcomp
General Hospital · 365d
Cleared Jun 28, 1996
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
K953805
Abbott Laboratories
General Hospital · 325d
Cleared May 09, 1996
VYGON LIFEVAC MID-LINE TRAY
K954112
Vygon Corp.
General Hospital · 283d
Cleared Feb 08, 1996
ABRM CATHETER
K950118
Cook, Inc.
General Hospital · 393d
Cleared Jan 23, 1996
MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER
K953335
Micro Therapeutics, Inc.
General Hospital · 190d
Cleared Dec 13, 1995
VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE
K952645
Vital Signs, Inc.
General Hospital · 187d
Cleared Dec 13, 1995
VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE
K953120
Vital Signs, Inc.
General Hospital · 161d
Cleared Sep 21, 1995
STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
K952058
Trinity Laboratories, Inc.
General Hospital · 142d
Cleared Jun 26, 1995
BIONECTOR
K941678
Vygon Corp.
General Hospital · 447d
Cleared Mar 22, 1995
MAHURKAR DUAL LUMEN CATHETER
K943349
Quinton, Inc.
General Hospital · 253d
Cleared Dec 12, 1994
PRN ADAPTER
K933467
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 514d
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 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 Dec 14, 1993
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
K933050
Critikon Company, LLC
General Hospital · 208d
Cleared Sep 28, 1992
SAFE-DWELL PLUS CENTRAL VENOUS CATHETER
K921270
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 195d
Cleared Apr 06, 1992
E-Z SET/MINICATH INFUSION SETS
K920635
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 54d
Cleared Apr 29, 1991
INJECTION CAPS
K910572
Akcess Medical Products, Inc.
General Hospital · 77d
Cleared Feb 11, 1991
DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL
K904558
Davol, Inc.
General Hospital · 129d