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
97–120 of 507
Cleared May 12, 2014
SUPERCATH5
K140419
Togo Medikit Co., Ltd.
General Hospital · 83d
Cleared Feb 14, 2014
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
K140136
Nipro Medical Corporation
General Hospital · 28d
Cleared Jan 31, 2014
MEDSOURCE IV SAFETY CATHETER
K131555
Medsource International, LLC
General Hospital · 247d
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 Apr 30, 2013
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
K130518
Luther Needlesafe Products, Inc.
General Hospital · 62d
Cleared Mar 05, 2013
JMS SAFE WING CATH (SWC)
K121488
JMS North America Corporation
General Hospital · 291d
Cleared Jan 17, 2013
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
K123734
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 43d
Cleared Dec 28, 2012
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1
K121007
Delta Med Srl
General Hospital · 269d
Cleared Nov 02, 2012
SURFFLASH(R) PLUS SAFETY I.V. CATHETER
K123267
Kofu Factory of Terumo Corp.
General Hospital · 14d
Cleared Sep 05, 2012
TERUMO SURFLASH SAFETY I.V. CATHETER
K122544
Terumo Corporation
General Hospital · 15d
Cleared Jul 20, 2012
NOVACATH SECURE IV CATHETER SYSTEM-18G
K120839
Tangent Medical Technologies, Inc.
General Hospital · 122d
Cleared Jul 11, 2012
M/29TM - PRESSURE INJECTABLE
K111939
Flexicath , Ltd.
General Hospital · 369d
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 May 18, 2012
ORION II CT CVC
K113622
Health Line International Corporation (Hlic)
General Hospital · 162d
Cleared Apr 16, 2012
SUPERCATH Z3V
K112290
Togo Medikit Co., Ltd.
General Hospital · 251d
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 Feb 16, 2012
I-PORT ADVANCE INJECTION PORT
K120337
Unomedical A/S
General Hospital · 13d
Cleared Feb 08, 2012
YOMURA SAFETY I.V. CATHETER
K112542
Yomura Technologies, Inc.
General Hospital · 160d
Cleared Dec 21, 2011
AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
K110794
Ameco Medical Industries
General Hospital · 274d
Cleared Sep 30, 2011
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
K111366
Becton, Dickinson and Company (BD)
General Hospital · 137d
Cleared Sep 22, 2011
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
K112347
Vascular Pathways, Inc.
General Hospital · 38d