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
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
Jun 30, 2004
CONTACT DETACH
Unomedical A/S
General Hospital
21d
Cleared
Jun 04, 2004
MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR
Medegen Medical Manufacturing Services, Inc.
General Hospital
29d
Cleared
May 19, 2004
CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
Smiths Medical MD, Inc.
General Hospital
70d
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
Cleared
Sep 08, 2003
MARQUETTE HUBER TRAP SAFETY INFUSION SET
Marquette Medical, Inc.
General Hospital
488d
Cleared
Aug 19, 2003
MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
Medtronic Minimed
General Hospital
57d
Cleared
Aug 11, 2003
ULTRASITE VALVE
B.Braun Medical, Inc.
General Hospital
49d
Cleared
May 30, 2003
SURSHIELD SAFETY WINGED INFUSION SET
Terumo Corp.
General Hospital
39d
Cleared
Feb 19, 2003
NEXUS INJECTION SITE (NIS), MODEL NIS-1
Nexus Medical, LLC
General Hospital
50d
Cleared
Jan 27, 2003
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
Abbott Laboratories
General Hospital
25d
Cleared
Aug 06, 2002
ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
Alaris Medical Systems, Inc.
General Hospital
29d
Cleared
Jul 08, 2002
SURECAN SAFETY HUBER NEEDLE INFUSION SETS
B.Braun Medical, Inc.
General Hospital
61d
Cleared
May 21, 2002
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
Sterling Medivations, Inc.
General Hospital
11d
Cleared
May 17, 2002
SIMPLICITY EASY ACCESS P INFUSION SET
Sterling Medivations, Inc.
General Hospital
9d
Cleared
May 14, 2002
SIMPLICITY QD EASY P INFUSION SET
Sterling Medivations, Inc.
General Hospital
20d
Cleared
May 03, 2002
SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS
Sterling Medivations, Inc.
General Hospital
16d