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..

507
Total
507
Cleared
142d
Avg days
1976
Since
507 devices
169–192 of 507
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 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 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 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 Apr 20, 2000
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
K992732
Dumex Medical Surgical Products, Ltd.
General Hospital · 251d
Cleared Apr 05, 2000
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
K000235
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 69d
Cleared Mar 17, 2000
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
K000087
The Kendal Co.
General Hospital · 65d
Cleared Mar 08, 2000
BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE
K982558
Bd/Preefil
General Hospital · 595d
Cleared Mar 08, 2000
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K993691
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
K993515
Medefil, Inc.
General Hospital · 130d
Cleared Dec 10, 1999
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
K990308
Rocap Div. of Sabratek Corp.
General Hospital · 312d
Cleared Dec 10, 1999
HEPARIN IV FLUSH SYRINGE, 10 U/ML \
K990390
Rocap Div. of Sabratek Corp.
General Hospital · 304d
Cleared Oct 07, 1999
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K984590
Baxter Healthcare Corp
General Hospital · 283d