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
Jun 09, 2011
SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
Elcam Medical Acal
General Hospital
58d
Cleared
Apr 27, 2011
LIGHTY DD INFUSION SET
Medx-Set, Ltd.
General Hospital
86d
Cleared
Mar 25, 2011
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
Baxter Healthcare Corp
General Hospital
113d
Cleared
Jan 07, 2011
HOSPIRA PLUM INFUSION SET
Hospira, Inc.
General Hospital
67d
Cleared
Dec 17, 2010
HIGH PRESSURE SETS-400 PSI
Icu Medical, Inc.
General Hospital
291d
Cleared
Dec 10, 2010
INFUSION SETS
Hospira, Inc.
General Hospital
25d
Cleared
Nov 10, 2010
BLOOD SAMPLING SET
Acacia, Inc.
General Hospital
14d
Cleared
Sep 29, 2010
AMSINO I.V. ADMINISTRATION AND EXTENSION SETS
Amsino International, Inc.
General Hospital
79d
Cleared
Aug 27, 2010
ACCU-CHEK ULTRFLEX INFUSION SET
Roche Diagnostics Corp.
General Hospital
120d
Cleared
Aug 11, 2010
HOSPIRA INFUSION BLOOD SETS
Hospira, Inc.
General Hospital
57d
Cleared
Aug 03, 2010
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,
Smiths Medical MD, Inc.
General Hospital
98d
Cleared
Aug 02, 2010
INTRAVSCULAR ADMINISTRATION SET
Terumo Europe N.V.
General Hospital
118d
Cleared
Jul 09, 2010
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS
Medtronic Minimed
General Hospital
143d
Cleared
Jul 09, 2010
CLAVE NEUTRON
Icu Medical, Inc.
General Hospital
143d
Cleared
Jun 22, 2010
DUAL LUER LOCK CAP, MODEL 2C6250
Baxter Healthcare Corp
General Hospital
35d
Cleared
Apr 26, 2010
NEXUS PRESSURE RATED EXTENSION SETS
Nexus Medical, LLC
General Hospital
264d
Cleared
Mar 10, 2010
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
Nexus Medical, LLC
General Hospital
169d
Cleared
Mar 10, 2010
AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS
Amsino International, Inc.
General Hospital
92d
Cleared
Feb 04, 2010
NEXUS INJECTION SITE, MODEL NIS-8
Nexus Medical, LLC
General Hospital
170d
Cleared
Jun 05, 2009
A6 LUER ACCESS DEVICE
B.Braun Medical, Inc.
General Hospital
172d
Cleared
Apr 21, 2009
INTRAVENOUS POWER INJECTOR EXTENSION SET
C.R. Bard, Inc.
General Hospital
90d
Cleared
Apr 10, 2009
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
Icu Medical, Inc.
General Hospital
74d
Cleared
Apr 06, 2009
SPINNING SPIROS, MODEL CH-2000
Icu Medical, Inc.
General Hospital
194d
Cleared
Dec 23, 2008
MISER CONTRAST MANAGEMENT SYSTEM
Merit Medical Systems, Inc.
General Hospital
20d