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
193–216 of 508
Cleared Dec 03, 2001
NIPRO SAFELET CATH
K013287
Nipro Medical Corp.
General Hospital · 62d
Cleared Nov 08, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
K013073
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 55d
Cleared Aug 28, 2001
TRULINE INFUSION CATHETERS
K011937
Micro Therapeutics, Inc.
General Hospital · 68d
Cleared Aug 01, 2001
PROTECTIV ACUVANCE IV CATHETER SYSTEM
K012128
Ethicon Endo-Surgery, Inc.
General Hospital · 23d
Cleared Jul 17, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K011982
Bd
General Hospital · 21d
Cleared Jun 27, 2001
KEYST0NE MEDICAL PICC CATHETER
K011860
Keystone Medical
General Hospital · 13d
Cleared Jun 20, 2001
JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
K010406
Jms Co., Ltd.
General Hospital · 128d
Cleared Jun 20, 2001
JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
K010410
Jms Co., Ltd.
General Hospital · 128d
Cleared Jun 20, 2001
NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET
K011297
Nipro Medical Corp.
General Hospital · 51d
Cleared May 21, 2001
VACUCATH I.V. CATHETER INTRODUCTER
K003187
Auto/Cath Vascular Access, Inc.
General Hospital · 222d
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
Cleared Feb 23, 2001
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
K010021
Medical Components, Inc.
General Hospital · 51d
Cleared Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034
Cook, Inc.
General Hospital · 20d
Cleared Dec 04, 2000
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
K003245
Baxter Healthcare Corp
General Hospital · 48d
Cleared Nov 17, 2000
BIOSENSORS CENTRAL VENOUS CATHETER KITS
K002786
Sunscope Intl., Inc.
General Hospital · 71d
Cleared Oct 19, 2000
0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
K000632
Avitro, LLC
General Hospital · 238d
Cleared Oct 19, 2000
THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD
K001795
Avitro, LLC
General Hospital · 127d
Cleared Sep 07, 2000
ZORTRAN DETECTOR
K000997
Lucent Medical Systems
General Hospital · 163d
Cleared Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K001616
Abbott Laboratories
General Hospital · 63d
Cleared Jul 26, 2000
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
K002033
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 21d
Cleared Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
K992532
Baxter Healthcare Corp
General Hospital · 320d
Cleared Jun 12, 2000
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL
K993518
Medefil, Inc.
General Hospital · 238d
Cleared May 02, 2000
TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K000665
Tfx Medical, Inc.
General Hospital · 64d
Cleared Apr 20, 2000
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
K992732
Dumex Medical Surgical Products, Ltd.
General Hospital · 251d