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
73–96 of 506
Cleared Dec 10, 2015
AccuCath Intravascular Catheter
K153298
C.R. Bard, Inc.
General Hospital · 27d
Cleared Jul 27, 2015
BD Angiocath IV Catheter, BD Insyte IV Catheter
K151698
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 33d
Cleared May 15, 2015
BioFlo Midline Catheter
K150407
Navilyst Medical, Inc.
General Hospital · 86d
Cleared Apr 09, 2015
BD INTIMA II CLOSED IV CATHETER
K143610
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 111d
Cleared Feb 14, 2014
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
K140136
Nipro Medical Corporation
General Hospital · 28d
Cleared Jan 16, 2014
POWERGLIDE MIDLINE CATHETER
K133856
C.R. Bard, Inc.
General Hospital · 28d
Cleared Dec 05, 2013
SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
K132153
Nipro Medical Corporation
General Hospital · 146d
Cleared Jan 17, 2013
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
K123734
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 43d
Cleared Jun 01, 2012
POWERGLIDE MIDLINE CATHETER
K121073
C.R. Bard, Inc.
General Hospital · 53d
Cleared May 18, 2012
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
K113565
Edwards Lifesciences, LLC
General Hospital · 168d
Cleared Mar 14, 2012
VIAVALVE SAFETY IV CATHETER
K113700
Smiths Medical Asd, Inc.
General Hospital · 89d
Cleared Mar 12, 2012
SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
K113429
Nipro Medical Corporation
General Hospital · 112d
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 Oct 13, 2009
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
K091709
Edwards Lifesciences, LLC
General Hospital · 125d
Cleared Apr 15, 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
K082997
Terumo Medical Corp.
General Hospital · 189d
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 Sep 29, 2006
MULTICATH EXPERT
K061250
Vygon Corp.
General Hospital · 148d