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
Aug 27, 1999
URETHANE PICC LINE MODEL UPICS-
Cook, Inc.
General Hospital
58d
Cleared
Aug 20, 1999
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT
Johnson & Johnson Medical, Div. of Ethicon, Inc.
General Hospital
207d
Cleared
Jun 16, 1999
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
Terumo Medical Corp.
General Hospital
55d
Cleared
May 27, 1999
NORMAL SALINE FLUSH SYRINGE
Rocap Div. of Sabratek Corp.
General Hospital
149d
Cleared
May 05, 1999
ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER
Maxxim Medical
General Hospital
163d
Cleared
Apr 09, 1999
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
147d
Cleared
Jan 29, 1999
CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS
Sims Deltec, Inc.
General Hospital
77d
Cleared
Jan 14, 1999
INTROCAN SAFETY IV CATHETER
B.Braun Medical, Inc.
General Hospital
157d
Cleared
Dec 16, 1998
BRAUN PREFILLED SYRINGE
B.Braun Medical, Inc.
General Hospital
656d
Cleared
Nov 23, 1998
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)
Hdc Corp.
General Hospital
20d
Cleared
Oct 16, 1998
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1
Hdc Corp.
General Hospital
18d
Cleared
Sep 14, 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
Boston Scientific Corp
General Hospital
213d
Cleared
Aug 18, 1998
STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291
Acu-Pak
General Hospital
78d
Cleared
May 18, 1998
ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
Davis & Geck, Inc.
General Hospital
208d
Cleared
May 11, 1998
MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M
Medical Components, Inc.
General Hospital
234d
Cleared
May 01, 1998
PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS
Catheter Innovations, Inc.
General Hospital
16d
Cleared
May 01, 1998
PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS
Catheter Innovations, Inc.
General Hospital
15d
Cleared
Apr 28, 1998
I.V. CATHETER SYSTEM
Johnson & Johnson Medical, Inc.
General Hospital
78d
Cleared
Feb 26, 1998
INTROSYTE CATHETER
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
69d
Cleared
Feb 10, 1998
L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER
Luther Medical Products, Inc.
General Hospital
69d
Cleared
Dec 24, 1997
INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS
Becton Dickinson Vascular Access, Inc.
General Hospital
258d
Cleared
Nov 07, 1997
GESCO PER-Q-CATH PICC CATHETERS
Bard Access Systems, Inc.
General Hospital
182d
Cleared
Nov 07, 1997
GESCO PER-Q-CATH MIDLINE CATHETERS
Bard Access Systems, Inc.
General Hospital
182d
Cleared
Oct 17, 1997
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
Arrow Intl., Inc.
General Hospital
221d