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
73–96 of 507
Cleared Nov 15, 2016
AccuCath Intravascular Catheter
K162894
C.R. Bard, Inc.
General Hospital · 29d
Cleared Nov 03, 2016
MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
K161779
Medsource International, LLC
General Hospital · 127d
Cleared Sep 22, 2016
PowerGlide Pro Midline Catheter
K162377
C.R. Bard, Inc.
General Hospital · 29d
Cleared Sep 08, 2016
BioFlo Midline Catheter
K161866
Navilyst Medical, Inc.
General Hospital · 63d
Cleared Aug 29, 2016
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
K161777
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 61d
Cleared Aug 12, 2016
SUPERCATH 6
K160592
Togo Medikit Co., Ltd.
General Hospital · 164d
Cleared Jun 30, 2016
ViaValve Safety I.V. Catheter
K160235
Smiths Medical Asd, Inc.
General Hospital · 150d
Cleared Jun 02, 2016
PowerGlide Pro Midline Catheter
K153280
C.R. Bard, Inc.
General Hospital · 203d
Cleared Mar 11, 2016
20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System
K160374
Tangent Medical Technologies, Inc.
General Hospital · 30d
Cleared Dec 10, 2015
AccuCath Intravascular Catheter
K153298
C.R. Bard, Inc.
General Hospital · 27d
Cleared Nov 23, 2015
Arrow Endurance Extended Dwell Peripheral Catheter System
K152272
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
General Hospital · 103d
Cleared Jul 27, 2015
BD Angiocath IV Catheter, BD Insyte IV Catheter
K151698
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 33d
Cleared Jul 15, 2015
MedSource ClearSafe Safety IV Catheter
K150611
Medsource International
General Hospital · 127d
Cleared Jul 08, 2015
Arrow Endurance Extended Dwell Peripheral Catheter System
K151513
Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)
General Hospital · 34d
Cleared Jun 18, 2015
I.V. Catheter
K142797
Jiangxi Sanxin Medtec Co., Ltd.
General Hospital · 262d
Cleared Jun 05, 2015
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
K150109
Arrow International (A Subsidiary of Teleflex, Inc.)
General Hospital · 136d
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 Jan 08, 2015
ACCUCATH MIDLINE CATHETER SYSTEM
K142136
Vascular Pathways, Inc.
General Hospital · 157d
Cleared Aug 20, 2014
NEXUS MIDLINE CT CATHETER
K140270
Health Line International Corporation
General Hospital · 198d
Cleared Jul 30, 2014
LEADERFLEX
K141026
Vygon
General Hospital · 99d
Cleared Jul 17, 2014
ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
K140504
Vascular Pathways, Inc.
General Hospital · 140d
Cleared Jun 12, 2014
TERUMO SURFLO I.V. CATHETER
K133280
Terumo (Philippines) Corporation
General Hospital · 230d
Cleared May 30, 2014
SURFLASH SAFETY I.V. CATHETER
K141138
Kofu Factory of Terumo Corp.
General Hospital · 28d