FDA Product Code FPA: Set, Administration, Intravascular
Intravenous administration sets are among the most fundamental devices in hospital care. FDA product code FPA covers intravascular administration sets used to deliver fluids, medications, and blood products.
These sets consist of tubing, drip chambers, flow regulators, and connectors that link IV bags or bottles to the patient's vascular access device. They are used across virtually every clinical setting, from emergency departments to intensive care units.
FPA devices are Class II medical devices, regulated under 21 CFR 880.5440 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Baxter Healthcare Corp, Abbott Laboratories and Y.
1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
Cleared
Mar 15, 2001
SURSHIELD WINGED INFUSION SET
Terumo Medical Corp.
General Hospital
62d
Cleared
Mar 13, 2001
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
Sterling Medivations, Inc.
General Hospital
34d
Cleared
Mar 06, 2001
SWABSITE SWABBABLE VALVE, MODEL 245000
Quest Medical, Inc.
General Hospital
189d
Cleared
Jan 11, 2001
TAXOL ADMINISTRATION SET
Icu Medical, Inc.
General Hospital
58d
Cleared
Dec 13, 2000
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
Sterling Medivations, Inc.
General Hospital
55d
Cleared
Oct 24, 2000
SIMPLICITY SOFT INFUSION SET
Sterling Medivations, Inc.
General Hospital
71d
Cleared
Oct 19, 2000
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
Baxter Healthcare Corp
General Hospital
3d
Cleared
Aug 10, 2000
LIFESHIELD ADDITIVE PIERCING PIN
Abbott Laboratories
General Hospital
38d
Cleared
May 31, 2000
SURGEN VALVE
Tiva Medical
General Hospital
484d
Cleared
May 10, 2000
POSI-LINK
Icu Medical, Inc.
General Hospital
86d
Cleared
Apr 27, 2000
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
Sims Deltec, Inc.
General Hospital
35d
Cleared
Mar 03, 2000
VENUSA, LTD. EXTENSION SET WITH FILTER
Venusa , Ltd.
General Hospital
64d
Cleared
Feb 23, 2000
EXEL INJECTION PLUG WITH CAP
Exel Intl.
General Hospital
231d
Cleared
Jan 27, 2000
MILLENNIUM HUBER PLUS SAFETY INFUSION SET
Millennium Medical Distribution, Inc.
General Hospital
76d
Cleared
Jan 04, 2000
INTRAVASCULAR ADMINISTRATION SET
Custom Assemblies, Inc.
General Hospital
83d
Cleared
Nov 05, 1999
DAISY PROTECTED SCALP VEIN SET
Diasol, Inc.
General Hospital
59d
Cleared
Nov 05, 1999
SHELLY PROTECTED AV FISTULA NEEDLE
Diasol, Inc.
General Hospital
43d
Cleared
Nov 02, 1999
DECAP
The Kipp Group
General Hospital
42d
Cleared
Oct 27, 1999
IV ADMINISTRATION SET
New Alliance of Independent Medical Distributors,
General Hospital
113d
Cleared
Oct 14, 1999
ECOMED SCALP VEIN SET
Greiner Meditech, Inc.
General Hospital
112d
Cleared
Sep 15, 1999
BOLUS ACCESSORY SET
I-Flow Corp.
General Hospital
88d
Cleared
Sep 15, 1999
NAC PRN NEEDLELESS ACCESS CONNECTOR
The Kipp Group
General Hospital
71d
Cleared
Sep 03, 1999
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321
Medtronic Minimed
General Hospital
81d
Cleared
Sep 02, 1999
SAGE CONTRAST MANAGEMENT SYSTEM
Sage Laboratories, Inc.
General Hospital
154d