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
Aug 23, 2005
VITALCARE I.V. ADMINISTRATION SET
Vitalcare Group, Inc.
General Hospital
134d
Cleared
Aug 03, 2005
CML 1000
Icu Medical, Inc.
General Hospital
63d
Cleared
Jul 13, 2005
ANGIODYNAMICS TUMESCENT INFUSION DEVICE
AngioDynamics, Inc.
General Hospital
70d
Cleared
Jul 12, 2005
HUBER CLEAR SAFETY INFUSION SET
Now Medical Distribution, Inc.
General Hospital
82d
Cleared
Jun 22, 2005
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
Medegen Medical Manufacturing Services
General Hospital
15d
Cleared
May 12, 2005
MINILOC SAFETY INFUSION SET
Specialized Health Products, Intl.
General Hospital
64d
Cleared
Apr 15, 2005
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
Pentaferte S.P.A
General Hospital
315d
Cleared
Apr 15, 2005
MICROFLO-SAFE SCALP VEIN SET
Dks Loversan Industria Biomedica Spa
General Hospital
134d
Cleared
Apr 07, 2005
BD POSIFLOW POSITIVE DISPLACEMENT VALVE
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
69d
Cleared
Mar 08, 2005
DRAGON HEART I.V. SET
Dragon Heart Medical Devices Co., Ltd.
General Hospital
106d
Cleared
Jan 27, 2005
F00010 - IV GRAVITY SETWITH MALE LUER SLIP
Cedic S.R.L.
General Hospital
174d
Cleared
Dec 21, 2004
LUTH-ALL SUB-Q NEEDLE SET
Luth-All Medical Products, LLC
General Hospital
83d
Cleared
Nov 26, 2004
NEXUS INTRAVENOUS TUBING SETS (NIVTS)
Nexus Medical, LLC
General Hospital
140d
Cleared
Nov 26, 2004
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
Baxter Healthcare Corp
General Hospital
32d
Cleared
Oct 29, 2004
IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
B.Braun Medical, Inc.
General Hospital
147d
Cleared
Oct 21, 2004
IV ADMINISTRATION SET B400 SP
Codan US Corp.
General Hospital
21d
Cleared
Oct 07, 2004
CLEO 90 INFUSION SET
Smiths Medical MD, Inc.
General Hospital
57d
Cleared
Oct 04, 2004
PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606
Clinico
General Hospital
80d
Cleared
Sep 17, 2004
EZ HUBER SAFETY INFUSION SET
Pfm Medical, Inc.
General Hospital
200d
Cleared
Sep 08, 2004
MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
Specialty Health Products, Inc.
General Hospital
21d
Cleared
Sep 03, 2004
ALL SAFE HUBER SAFETY INFUSION SETS
Nexus Medical, LLC
General Hospital
57d
Cleared
Sep 01, 2004
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
Icu Medical, Inc.
General Hospital
21d
Cleared
Aug 24, 2004
NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4
Nexus Medical, LLC
General Hospital
47d
Cleared
Aug 11, 2004
TEGO NEEDLE FREE ACCESS ACCESS DEVICE
Icu Medical, Inc.
General Hospital
146d