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
Nov 14, 2008
NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS
Nexus Medical, LLC
General Hospital
207d
Cleared
Oct 21, 2008
NIPRO SAFETOUCH HUBER INFUSTION SET
Nipro Medical Corp.
General Hospital
175d
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
Cleared
Jul 18, 2008
CADD MEDICATION CASSETTE RESERVOIR
Smiths Medical MD, Inc.
General Hospital
86d
Cleared
Dec 13, 2007
SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET
AngioDynamics, Inc.
General Hospital
112d
Cleared
Nov 06, 2007
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED
Baxter Healthcare Corp
General Hospital
54d
Cleared
Nov 06, 2007
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
Terumo Europe N.V.
General Hospital
26d
Cleared
Aug 30, 2007
MODIFICATION TO EZ HUBER SAFETY INFUSION SET
Pfm Medical, Inc.
General Hospital
56d
Cleared
May 25, 2007
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
Terumo Europe N.V.
General Hospital
88d
Cleared
May 07, 2007
SURFLO WINGED INFUSION SET
Terumo Europe N.V.
General Hospital
89d
Cleared
Mar 20, 2007
SPIROS
Icu Medical, Inc.
General Hospital
22d
Cleared
Jul 10, 2006
EZ-CONNECT
Vidacare Corporation
General Hospital
17d
Cleared
Mar 29, 2006
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
Baxter Healthcare Corp
General Hospital
78d
Cleared
Jan 10, 2006
TEGO, MODEL D1000
Icu Medical, Inc.
General Hospital
67d
Cleared
Dec 08, 2005
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS
Terumo Europe N.V.
General Hospital
56d
Cleared
Dec 08, 2005
NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5
Nexus Medical, LLC
General Hospital
30d
Cleared
Nov 29, 2005
MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2
Medtronic Minimed
General Hospital
84d
Cleared
Nov 16, 2005
CONTRAST MEDIA TRANSFER SETS
B.Braun Medical, Inc.
General Hospital
90d
Cleared
Nov 02, 2005
LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS
Hospira, Inc.
General Hospital
34d
Cleared
Sep 01, 2005
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
Unomedical A/S
General Hospital
108d