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..

508
Total
508
Cleared
143d
Avg days
1976
Since
508 devices
169–192 of 508
Cleared Mar 22, 2004
BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
K032292
Bioteque Corp.
General Hospital · 242d
Cleared Feb 27, 2004
NEXIVA CLOSED IV CATHETER SYSTEM
K032843
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 169d
Cleared Feb 26, 2004
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
K032274
Cook, Inc.
General Hospital · 218d
Cleared Jan 29, 2004
BD CAREFLOW CENTRAL VENOUS CATHETER
K033500
Becton, Dickinson & CO
General Hospital · 85d
Cleared Jan 14, 2004
MODIFICATION TO V-CATH POLY PICC
K033853
Hdc Corp.
General Hospital · 34d
Cleared Dec 30, 2003
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
K033250
Edwards Lifesciences, LLC
General Hospital · 84d
Cleared Dec 23, 2003
HEPARIN LOCK FLUSH SYRINGE
K032417
Am2 Pat, Inc.
General Hospital · 140d
Cleared Nov 14, 2003
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
K032777
Nipro Medical Corp.
General Hospital · 67d
Cleared Oct 29, 2003
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
K032962
Arrow Intl., Inc.
General Hospital · 36d
Cleared Aug 18, 2003
JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET
K030479
Jms North America Corp.
General Hospital · 186d
Cleared Jul 14, 2003
SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J
K024007
Sunder Biomedical Tech. Co., Ltd.
General Hospital · 222d
Cleared May 30, 2003
SPECTRUM SILICONE CATHETER
K021557
Cook, Inc.
General Hospital · 382d
Cleared May 06, 2003
PEDIATRIC CENTRAL VENOUS CATHETER KIT
K023253
B.Braun Medical, Inc.
General Hospital · 218d
Cleared Mar 28, 2003
ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER
K030571
Ethicon Endo-Surgery, Inc.
General Hospital · 32d
Cleared Jan 07, 2003
SPECATH CENTRAL VENOUS CATHETER KITS
K021130
Special Medical Co. , Ltd.
General Hospital · 273d
Cleared Oct 18, 2002
NIPRO BIO-FLEX CATHETER
K022756
Nipro Medical Corp.
General Hospital · 59d
Cleared Sep 20, 2002
SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S
K022099
Hdc Corp.
General Hospital · 85d
Cleared Aug 28, 2002
INTROCAN SAFETY IV CATHETER
K020785
B.Braun Medical, Inc.
General Hospital · 170d
Cleared Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182
Cook, Inc.
General Hospital · 280d
Cleared Apr 17, 2002
TRULINE REINFORCED VALVED INFUSION CATHETER
K021139
Micro Therapeutics, Inc.
General Hospital · 8d
Cleared Jan 28, 2002
SALINE IV FLUSH SYRINGE
K002142
Emt-Rx
General Hospital · 560d
Cleared Jan 23, 2002
BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE
K011967
Bd
General Hospital · 212d
Cleared Dec 31, 2001
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
K013556
Tyco Healthcare
General Hospital · 67d
Cleared Dec 21, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE
K013800
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 36d