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., Bd Becton Dickinson Vacutainer Systems Preanalytic and C.R. Bard, Inc..

504
Total
504
Cleared
142d
Avg days
1976
Since
504 devices
49–72 of 504
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 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 Mar 10, 2017
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
K170336
Becton, Dickinson and Company
General Hospital · 36d
Cleared Feb 28, 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283
Becton, Dickinson and Company
General Hospital · 29d
Cleared Nov 15, 2016
AccuCath Intravascular Catheter
K162894
C.R. Bard, Inc.
General Hospital · 29d
Cleared Sep 22, 2016
PowerGlide Pro Midline Catheter
K162377
C.R. Bard, Inc.
General Hospital · 29d
Cleared Jun 02, 2016
PowerGlide Pro Midline Catheter
K153280
C.R. Bard, Inc.
General Hospital · 203d
Cleared Dec 10, 2015
AccuCath Intravascular Catheter
K153298
C.R. Bard, Inc.
General Hospital · 27d
Cleared Jan 16, 2014
POWERGLIDE MIDLINE CATHETER
K133856
C.R. Bard, Inc.
General Hospital · 28d
Cleared Jun 01, 2012
POWERGLIDE MIDLINE CATHETER
K121073
C.R. Bard, Inc.
General Hospital · 53d
Cleared Apr 14, 2006
SHERLOCK TIP LOCATION SYSTEM (TLS)
K060341
C.R. Bard, Inc.
General Hospital · 63d
Cleared Mar 21, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K003553
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 124d