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
Cleared
Feb 08, 2008
VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM
Vascular Pathways
General Hospital
84d
Cleared
Nov 30, 2007
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
Vygon Corp.
General Hospital
261d
Cleared
Nov 09, 2007
ADVANTIV SAFETY I.V. CATHETER
Smiths Medical Asd, Inc.
General Hospital
73d
Cleared
Oct 16, 2007
SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,
Shinchang Medical Co., Ltd.
General Hospital
152d
Cleared
Aug 30, 2007
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
Arrow International, Inc.
General Hospital
86d
Cleared
Aug 16, 2007
COMCASET-P SAFETY IV CATHETER
Pitango Medical, Ltd.
General Hospital
225d
Cleared
Jul 31, 2007
ABLE CENTRAL VENOUS CATHETER
Foshan Nanhai Bai HE Medical Technology Co., Ltd.
General Hospital
166d
Cleared
Dec 01, 2006
MEDICAN ALPHA
Eastern Medikit , Ltd.
General Hospital
15d
Cleared
Sep 29, 2006
MULTICATH EXPERT
Vygon Corp.
General Hospital
148d
Cleared
Aug 08, 2006
COMCASET SAFETY IV CATHETER
Pitango Medical, Ltd.
General Hospital
15d
Cleared
Apr 14, 2006
SHERLOCK TIP LOCATION SYSTEM (TLS)
C.R. Bard, Inc.
General Hospital
63d
Cleared
Apr 05, 2006
VYGON LEADER-FLEX
Vygon Corp.
General Hospital
198d
Cleared
Mar 02, 2006
VYGON LATEX FREE BIONECTOR
Vygon Corp.
General Hospital
141d
Cleared
Feb 17, 2006
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
Cook, Inc.
General Hospital
25d
Cleared
Jan 19, 2006
CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
Myco Medical Supplies, Inc.
General Hospital
491d
Cleared
Dec 09, 2005
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
Excelsior Medical Corp.
General Hospital
32d
Cleared
Sep 23, 2005
VANISHPOINT I.V. CATHETER
Retractable Technologies, Inc.
General Hospital
122d
Cleared
Sep 09, 2005
I-PORT
Patton Medical Devices
General Hospital
9d
Cleared
Jun 09, 2005
SUPERCATH Z3V
Togo Medikit Co., Ltd.
General Hospital
142d
Cleared
Feb 04, 2005
EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
Emmebi Srl
General Hospital
52d
Cleared
Dec 03, 2004
BD ONECATH
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
49d
Cleared
Aug 12, 2004
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
Cook, Inc.
General Hospital
246d
Cleared
Jul 22, 2004
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
Medix, Inc.
General Hospital
63d
Cleared
May 03, 2004
FIBREX CATHETER PATENCY DEVICE
Medical Device Technologies, Inc.
General Hospital
74d