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..

508
Total
508
Cleared
143d
Avg days
1976
Since
508 devices
121–144 of 508
Cleared Sep 22, 2011
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
K112347
Vascular Pathways, Inc.
General Hospital · 38d
Cleared Aug 30, 2011
INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
K111236
B.Braun Melsungen AG
General Hospital · 120d
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 Feb 26, 2010
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
K100282
Terumo Corp.
General Hospital · 25d
Cleared Dec 17, 2009
SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX
K093546
Togo Medikit Co., Ltd.
General Hospital · 30d
Cleared Oct 13, 2009
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
K091709
Edwards Lifesciences, LLC
General Hospital · 125d
Cleared Sep 25, 2009
SNM FIRMGRIP
K092629
Flexicath , Ltd.
General Hospital · 29d
Cleared Aug 07, 2009
I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT
K083429
Weihai Jierui Medical Products Co., Ltd.
General Hospital · 261d
Cleared May 01, 2009
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
K090973
Terumo Corp.
General Hospital · 25d
Cleared Apr 15, 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
K082997
Terumo Medical Corp.
General Hospital · 189d
Cleared Mar 12, 2009
SUPERCATH 5
K081953
Togo Medikit Co., Ltd.
General Hospital · 246d
Cleared Mar 10, 2009
NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
K090502
U.S. Safety Syringes Co., Inc.
General Hospital · 13d
Cleared Feb 05, 2009
NUOVOGUARD
K090122
U.S. Safety Syringes Co., Inc.
General Hospital · 15d
Cleared Dec 04, 2008
NUOVOCATH
K083454
U.S. Safety Syringes Co., Inc.
General Hospital · 13d
Cleared Nov 07, 2008
VANISHPOINT I.V. CATHETER
K081420
Retractable Technologies, Inc.
General Hospital · 171d
Cleared Oct 16, 2008
FIRMGRIP
K080793
Flexicath , Ltd.
General Hospital · 210d
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 Apr 30, 2008
VANTAGECATH INTRAVASCULAR CATHETER
K073471
Advantage Medical Device
General Hospital · 141d
Cleared Apr 11, 2008
ANGIOTECH CVC
K073520
Angiotech Pharmaceuticals, Inc.
General Hospital · 119d