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
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
Mar 20, 2007
SPIROS
Icu Medical, Inc.
General Hospital
22d
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
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
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
Apr 07, 2005
BD POSIFLOW POSITIVE DISPLACEMENT VALVE
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
69d
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
Sep 01, 2004
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
Icu Medical, Inc.
General Hospital
21d
Cleared
Aug 11, 2004
TEGO NEEDLE FREE ACCESS ACCESS DEVICE
Icu Medical, Inc.
General Hospital
146d
Cleared
Jul 28, 2004
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
Icu Medical, Inc.
General Hospital
62d
Cleared
Jul 16, 2004
SPLIT SEPTUM INJECTION SITES
Fresenius Medical Care North America
General Hospital
85d
Cleared
Apr 12, 2004
TALON INFUSION SET, MODEL IP XXXX
Icu Medical, Inc.
General Hospital
181d
Cleared
Apr 07, 2004
MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
Quest Medical, Inc.
General Hospital
50d
Cleared
Dec 04, 2003
CLC2000 CATHETER PATENCY DEVICE
Icu Medical, Inc.
General Hospital
561d
Cleared
Dec 04, 2003
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
Abbott Laboratories
General Hospital
21d
Cleared
Nov 18, 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
Becton, Dickinson & CO
General Hospital
29d
Cleared
Oct 28, 2003
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
Medtronic Minimed
General Hospital
77d
Cleared
Oct 28, 2003
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
Medtronic Minimed
General Hospital
77d