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 02, 1991
3RD HAND HELPER
Aaron Medical Industries
General Hospital
100d
Cleared
Jun 24, 1991
INTERLINK(TM) BLUNT CANNULA, MODIFICATION
Baxter Healthcare Corp
General Hospital
59d
Cleared
Jun 14, 1991
B-D SAFETY-LOK(TM) I.V. NEEDLES
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
92d
Cleared
Jun 04, 1991
4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP
Marquette Medical, Inc.
General Hospital
196d
Cleared
Jun 04, 1991
4' LOW VOLUME IV EXTENSION SET
Marquette Medical, Inc.
General Hospital
196d
Cleared
May 31, 1991
IV EXTENSION SETS WITH .22 MICRON FILTER
Marquette Medical, Inc.
General Hospital
183d
Cleared
Apr 29, 1991
PIGGY LOCK NEEDLE HOUSING
Icu Medical, Inc.
General Hospital
82d
Cleared
Dec 14, 1990
AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET
3M Avi, Inc.
General Hospital
168d
Cleared
Nov 21, 1990
EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)
Exel Intl.
General Hospital
48d
Cleared
Nov 13, 1990
STERILE I.V. START KIT
Orion Life Systems, Inc.
General Hospital
139d
Cleared
Oct 04, 1990
LOW VOLUME BIFURCATED IV EXTENSION SET
Marquette Medical, Inc.
General Hospital
211d
Cleared
Oct 04, 1990
LOW VOLUME TRIFURCATED IV EXTENSION SET
Marquette Medical, Inc.
General Hospital
211d
Cleared
Sep 12, 1990
KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET
Kawasumi Laboratories Co., Ltd.
General Hospital
278d
Cleared
Sep 12, 1990
KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE
Kawasumi Laboratories Co., Ltd.
General Hospital
278d
Cleared
Sep 12, 1990
KAWASUMI BLOOD ADMINISTRATION SET
Kawasumi Laboratories Co., Ltd.
General Hospital
278d
Cleared
Sep 12, 1990
KAWASUMI I.V. ADMINISTRATION SET
Kawasumi Laboratories Co., Ltd.
General Hospital
278d
Cleared
Sep 12, 1990
KAWASUMI SMALL VEIN INFUSION SET
Kawasumi Laboratories Co., Ltd.
General Hospital
278d
Cleared
Aug 17, 1990
WINGED INFUSION SET
Therex Corp.
General Hospital
94d
Cleared
Jul 19, 1990
EXEL HUBER INFUSION SET
Exel Intl.
General Hospital
296d
Cleared
May 18, 1990
IN-LINE VIAL CONNECTION SITE
Baxter Healthcare Corp
General Hospital
80d
Cleared
May 01, 1990
ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)
Advance Medical Designs, Inc.
Radiology
105d
Cleared
May 01, 1990
ADVANCE ADMINISTRATION SETS (VARYING LENGTH)
Advance Medical Designs, Inc.
Radiology
105d
Cleared
Feb 28, 1990
IV BIFURCATED EXTENSION SET
Marquette Medical, Inc.
General Hospital
29d
Cleared
Feb 28, 1990
IV TRIFURCATED EXTENSION SET
Marquette Medical, Inc.
General Hospital
29d