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 21, 2012
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
Hospira, Inc.
General Hospital
77d
Cleared
Jan 12, 2012
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
Hospira, Inc.
General Hospital
28d
Cleared
Nov 26, 2011
CYTOGUARD(TM) CLOSED LUER CONNECTOR
B.Braun Medical, Inc.
General Hospital
78d
Cleared
Oct 18, 2011
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
Baxter Healthcare Corporation
General Hospital
15d
Cleared
Jul 21, 2011
INFUSION SET FOR POWERPICC SOLO 2 CATHETER
C.R. Bard, Inc.
General Hospital
331d
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
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
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
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
Cleared
Aug 28, 2008
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
Icu Medical, Inc.
General Hospital
105d
Cleared
Aug 28, 2008
POWERLOC CLEAR SAFETY INFUSION SET
C.R. Bard, Inc.
General Hospital
15d
Cleared
Aug 14, 2008
UNASSIGNED
Medcomp
General Hospital
169d
Cleared
Aug 07, 2008
ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG
B.Braun Medical, Inc.
General Hospital
248d
Cleared
Aug 04, 2008
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
Baxter Healthcare Corp
General Hospital
89d