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
49–72 of 507
Cleared Aug 07, 2020
MedSource CathMED IV Catheter
K193278
Medsource Labs
General Hospital · 254d
Cleared Apr 23, 2020
MF SAFECATH
K192230
Medifirst Co., Ltd.
General Hospital · 251d
Cleared Apr 07, 2020
BD Centro Vena Acute Central Line (7 French Dual Lumen)
K200266
Bard Access Systems, Inc. (Bard Has Joined Bd)
General Hospital · 64d
Cleared Apr 01, 2020
Introcan Safety 2 IV Catheter 18-24 gauge
K192676
B.Braun Medical, Inc.
General Hospital · 188d
Cleared Mar 12, 2020
Health Line CT Midline Catheter
K200263
Health Line International Corporation
General Hospital · 38d
Cleared Jan 24, 2020
BD Cathena (TM) Safety IV Catheter
K192493
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 135d
Cleared Dec 10, 2019
Health Line CT CVC
K192533
Health Line International Corporation
General Hospital · 85d
Cleared Nov 01, 2019
BD Acute Central Line
K190855
Bard Access Systems, Inc. (Bard Has Joined Bd)
General Hospital · 213d
Cleared Sep 20, 2019
Supercath 5
K190001
Togo Medikit Co., Ltd.
General Hospital · 261d
Cleared Sep 18, 2019
AccuCath Ace Intravascular Catheter
K191232
C.R. Bard, Inc.
General Hospital · 133d
Cleared May 17, 2019
Cook Unimpregnated Central Venous Catheter
K182252
Cook Incorporated
General Hospital · 270d
Cleared Mar 20, 2019
BD Nexiva Closed IV Catheter System
K183399
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 103d
Cleared Mar 07, 2019
Introcan Safety 3 Closed IV Catheter
K182870
B.Braun Medical, Inc.
General Hospital · 146d
Cleared Jan 16, 2019
Merit RadialFlo Arterial Catheter
K182538
Merit Medical Singapore Pte. , Ltd.
Cardiovascular · 124d
Cleared Mar 23, 2018
SUPERCATH 5 (26G)
K172496
Togo Medikit Co., Ltd.
General Hospital · 217d
Cleared Dec 21, 2017
Deltaven XiV Max, Deltaven XiV Max FF
K171530
Delta Med Spa
General Hospital · 210d
Cleared Dec 15, 2017
BD Nexiva Diffusics Closed IV Catheter Systems
K173354
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 51d
Cleared Sep 17, 2017
BD Cathena Safety IV Catheter
K172506
Becton, Dickinson and Company
General Hospital · 30d
Cleared Aug 17, 2017
BD Intima II PLUS Closed IV Catheter System
K172204
Becton, Dickinson and Company
General Hospital · 27d
Cleared Apr 28, 2017
Introcan Safety 3 Closed IV Catheter
K163358
B.Braun Melsungen AG
General Hospital · 149d
Cleared Mar 10, 2017
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
K170336
Becton, Dickinson and Company
General Hospital · 36d
Cleared Mar 08, 2017
Nipro SafeTouch IV Catheter
K161681
Nipro Medical Corporation
General Hospital · 264d
Cleared Feb 28, 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283
Becton, Dickinson and Company
General Hospital · 29d
Cleared Feb 24, 2017
Arrow Endurance Extended Dwell Peripheral Catheter System
K163513
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
General Hospital · 71d