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
121–144 of 507
Cleared Aug 30, 2011
INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
K111236
B.Braun Melsungen AG
General Hospital · 120d
Cleared Jul 19, 2011
BD INSYTE AUTOGUARD BC
K110443
Becton, Dickinson & CO
General Hospital · 153d
Cleared Jan 06, 2011
BD NEXIVA CLOSED IV CATHETER SYSTEM
K102520
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 126d
Cleared Jun 03, 2010
BD INTIMA II CLOSED IV CATHETER
K100775
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 77d
Cleared May 06, 2010
SPECTRUM TURBO-JECT PICC SET
K100974
Cook Incorporated
General Hospital · 28d
Cleared Feb 26, 2010
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
K100282
Terumo Corp.
General Hospital · 25d
Cleared Dec 17, 2009
SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX
K093546
Togo Medikit Co., Ltd.
General Hospital · 30d
Cleared Oct 13, 2009
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
K091709
Edwards Lifesciences, LLC
General Hospital · 125d
Cleared May 01, 2009
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
K090973
Terumo Corp.
General Hospital · 25d
Cleared Apr 15, 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
K082997
Terumo Medical Corp.
General Hospital · 189d
Cleared Mar 12, 2009
SUPERCATH 5
K081953
Togo Medikit Co., Ltd.
General Hospital · 246d
Cleared Sep 17, 2008
SURSHIELD SAFETY I.V. CATHETER
K082362
Terumo Medical Corp.
General Hospital · 30d
Cleared Jul 30, 2008
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
K081113
Cook, Inc.
General Hospital · 103d
Cleared Jul 14, 2008
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
K081690
Cook, Inc.
General Hospital · 27d
Cleared Nov 30, 2007
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
K070705
Vygon Corp.
General Hospital · 261d
Cleared Nov 09, 2007
ADVANTIV SAFETY I.V. CATHETER
K072419
Smiths Medical Asd, Inc.
General Hospital · 73d
Cleared Aug 30, 2007
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
K071538
Arrow International, Inc.
General Hospital · 86d
Cleared Sep 29, 2006
MULTICATH EXPERT
K061250
Vygon Corp.
General Hospital · 148d
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 Jan 19, 2006
CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
K042504
Myco Medical Supplies, Inc.
General Hospital · 491d
Cleared Dec 09, 2005
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
K053120
Excelsior Medical Corp.
General Hospital · 32d