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
145–168 of 508
Cleared Feb 08, 2008
VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM
K073241
Vascular Pathways
General Hospital · 84d
Cleared Nov 30, 2007
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
K070705
Vygon Corp.
General Hospital · 261d
Cleared Nov 09, 2007
ADVANTIV SAFETY I.V. CATHETER
K072419
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,
K071382
Shinchang Medical Co., Ltd.
General Hospital · 152d
Cleared Aug 30, 2007
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
K071538
Arrow International, Inc.
General Hospital · 86d
Cleared Aug 16, 2007
COMCASET-P SAFETY IV CATHETER
K070020
Pitango Medical, Ltd.
General Hospital · 225d
Cleared Jul 31, 2007
ABLE CENTRAL VENOUS CATHETER
K070451
Foshan Nanhai Bai HE Medical Technology Co., Ltd.
General Hospital · 166d
Cleared Dec 01, 2006
MEDICAN ALPHA
K063469
Eastern Medikit , Ltd.
General Hospital · 15d
Cleared Sep 29, 2006
MULTICATH EXPERT
K061250
Vygon Corp.
General Hospital · 148d
Cleared Aug 08, 2006
COMCASET SAFETY IV CATHETER
K062108
Pitango Medical, Ltd.
General Hospital · 15d
Cleared Apr 14, 2006
SHERLOCK TIP LOCATION SYSTEM (TLS)
K060341
C.R. Bard, Inc.
General Hospital · 63d
Cleared Apr 05, 2006
VYGON LEADER-FLEX
K052564
Vygon Corp.
General Hospital · 198d
Cleared Mar 02, 2006
VYGON LATEX FREE BIONECTOR
K052881
Vygon Corp.
General Hospital · 141d
Cleared Feb 17, 2006
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
K060174
Cook, Inc.
General Hospital · 25d
Cleared Jan 19, 2006
CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
K042504
Myco Medical Supplies, Inc.
General Hospital · 491d
Cleared Dec 09, 2005
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
K053120
Excelsior Medical Corp.
General Hospital · 32d
Cleared Sep 23, 2005
VANISHPOINT I.V. CATHETER
K051355
Retractable Technologies, Inc.
General Hospital · 122d
Cleared Sep 09, 2005
I-PORT
K052389
Patton Medical Devices
General Hospital · 9d
Cleared Jun 09, 2005
SUPERCATH Z3V
K050114
Togo Medikit Co., Ltd.
General Hospital · 142d
Cleared Feb 04, 2005
EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
K043446
Emmebi Srl
General Hospital · 52d
Cleared Dec 03, 2004
BD ONECATH
K042862
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 49d
Cleared Aug 12, 2004
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
K033843
Cook, Inc.
General Hospital · 246d
Cleared Jul 22, 2004
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
K041345
Medix, Inc.
General Hospital · 63d
Cleared May 03, 2004
FIBREX CATHETER PATENCY DEVICE
K040427
Medical Device Technologies, Inc.
General Hospital · 74d