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
Apr 25, 2002
SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE
Sterling Medivations, Inc.
General Hospital
28d
Cleared
Apr 16, 2002
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
162d
Cleared
Apr 10, 2002
SIMPLICITY EASY SOFT INFUSION SET
Sterling Medivations, Inc.
General Hospital
21d
Cleared
Apr 10, 2002
SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
Sterling Medivations, Inc.
General Hospital
14d
Cleared
Apr 01, 2002
SIMPLICITY SIMPLEX SOFT INFUSION SET
Sterling Medivations, Inc.
General Hospital
34d
Cleared
Mar 29, 2002
LIFEGUARD SAFETY INFUSION SET
Horizon Medical Products, Inc.
General Hospital
128d
Cleared
Jan 17, 2002
SIMPLICITY STARPLUS SOFT INFUSION SET
Sterling Medivations, Inc.
General Hospital
38d
Cleared
Jan 17, 2002
SIMPLICITY EASY ACCESS INFUSION SET
Sterling Medivations, Inc.
General Hospital
38d
Cleared
Dec 03, 2001
SIMPLICITY CLASSIC WING QD INFUSION SET
Sterling Medivations, Inc.
General Hospital
42d
Cleared
Oct 15, 2001
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
Terumo Medical Corp.
General Hospital
24d
Cleared
Oct 02, 2001
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
Sterling Medivations, Inc.
General Hospital
15d
Cleared
Sep 14, 2001
SIMPLICITY SOFT QD MICRO INFUSION SET
Sterling Medivations, Inc.
General Hospital
22d
Cleared
Aug 10, 2001
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
Northgate Technologies, Inc.
General Hospital
51d
Cleared
Aug 10, 2001
SIMPLICITY EURO QD INFUSION SET
Sterling Medivations, Inc.
General Hospital
18d
Cleared
Jun 19, 2001
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
Sterling Medivations, Inc.
General Hospital
62d
Cleared
Jun 05, 2001
SIMPLICITY SOFT QD SILVER INFUSION SET
Sterling Medivations, Inc.
General Hospital
14d
Cleared
May 29, 2001
MEDISYSTEMS LUER ACCESS INJECTION SITE
Medisystems Corp.
General Hospital
119d
Cleared
Apr 30, 2001
SIMPLICITY WING INFUSION SET
Sterling Medivations, Inc.
General Hospital
38d
Cleared
Apr 20, 2001
SIMPLICITY SOFT QD EASY INFUSION SET
Sterling Medivations, Inc.
General Hospital
36d
Cleared
Apr 18, 2001
SIMPLICITY WINGED QD INFUSION SET
Sterling Medivations, Inc.
General Hospital
43d
Cleared
Apr 13, 2001
SIMPLICITY INFUSER INFUSION SET
Sterling Medivations, Inc.
General Hospital
39d
Cleared
Apr 12, 2001
SIMPLICITY SILVER SET SOFT INFUSION
Sterling Medivations, Inc.
General Hospital
22d
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