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..
507
Total
507
Cleared
142d
Avg days
1976
Since
507 devices
Cleared
Dec 03, 2001
NIPRO SAFELET CATH
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
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
55d
Cleared
Aug 28, 2001
TRULINE INFUSION CATHETERS
Micro Therapeutics, Inc.
General Hospital
68d
Cleared
Aug 01, 2001
PROTECTIV ACUVANCE IV CATHETER SYSTEM
Ethicon Endo-Surgery, Inc.
General Hospital
23d
Cleared
Jun 20, 2001
JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
Jms Co., Ltd.
General Hospital
128d
Cleared
Jun 20, 2001
JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
Jms Co., Ltd.
General Hospital
128d
Cleared
Jun 20, 2001
NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET
Nipro Medical Corp.
General Hospital
51d
Cleared
Mar 21, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
124d
Cleared
Feb 23, 2001
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
Medical Components, Inc.
General Hospital
51d
Cleared
Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
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
Baxter Healthcare Corp
General Hospital
48d
Cleared
Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
Abbott Laboratories
General Hospital
63d
Cleared
Jul 26, 2000
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
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
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
Medefil, Inc.
General Hospital
238d
Cleared
Apr 20, 2000
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
Dumex Medical Surgical Products, Ltd.
General Hospital
251d
Cleared
Apr 05, 2000
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
69d
Cleared
Mar 17, 2000
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
The Kendal Co.
General Hospital
65d
Cleared
Mar 08, 2000
BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE
Bd/Preefil
General Hospital
595d
Cleared
Mar 08, 2000
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
Arrow Intl., Inc.
General Hospital
128d
Cleared
Feb 25, 2000
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL
Medefil, Inc.
General Hospital
130d
Cleared
Dec 10, 1999
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
Rocap Div. of Sabratek Corp.
General Hospital
312d
Cleared
Dec 10, 1999
HEPARIN IV FLUSH SYRINGE, 10 U/ML \
Rocap Div. of Sabratek Corp.
General Hospital
304d
Cleared
Oct 07, 1999
0.9% SODIUM CHLORIDE FLUSH SYRINGE
Baxter Healthcare Corp
General Hospital
283d