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
97–120 of 506
Cleared Apr 14, 2006
SHERLOCK TIP LOCATION SYSTEM (TLS)
K060341
C.R. Bard, Inc.
General Hospital · 63d
Cleared Apr 05, 2006
VYGON LEADER-FLEX
K052564
Vygon Corp.
General Hospital · 198d
Cleared Mar 02, 2006
VYGON LATEX FREE BIONECTOR
K052881
Vygon Corp.
General Hospital · 141d
Cleared Feb 17, 2006
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
K060174
Cook, Inc.
General Hospital · 25d
Cleared Dec 03, 2004
BD ONECATH
K042862
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 49d
Cleared Aug 12, 2004
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
K033843
Cook, Inc.
General Hospital · 246d
Cleared May 03, 2004
FIBREX CATHETER PATENCY DEVICE
K040427
Medical Device Technologies, Inc.
General Hospital · 74d
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 Dec 30, 2003
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
K033250
Edwards Lifesciences, LLC
General Hospital · 84d
Cleared Oct 29, 2003
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
K032962
Arrow Intl., Inc.
General Hospital · 36d
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 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 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
Cleared Nov 08, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
K013073
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 55d
Cleared Aug 28, 2001
TRULINE INFUSION CATHETERS
K011937
Micro Therapeutics, Inc.
General Hospital · 68d
Cleared Aug 01, 2001
PROTECTIV ACUVANCE IV CATHETER SYSTEM
K012128
Ethicon Endo-Surgery, Inc.
General Hospital · 23d
Cleared Mar 21, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K003553
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 124d
Cleared Feb 23, 2001
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
K010021
Medical Components, Inc.
General Hospital · 51d