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
Jun 18, 1993
SHROUDED NEEDLE DEVICES
Imed Corp.
General Hospital
270d
Cleared
Jun 18, 1993
INTERLINK(TM) INJECTION SITE
Baxter Healthcare Corp
General Hospital
248d
Cleared
May 26, 1993
AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET
3M Health Care, Ltd.
General Hospital
279d
Cleared
Apr 20, 1993
INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET
Baxter Healthcare Corp
General Hospital
363d
Cleared
Nov 05, 1992
LIFESHIELD ANESTHESIA SET
Abbott Laboratories
General Hospital
427d
Cleared
Oct 19, 1992
INTERLINK(TM) INJECTION SITE
Baxter Healthcare Corp
General Hospital
144d
Cleared
Oct 13, 1992
SUBCUTANEOUS INFUSION SET
Marquette Medical, Inc.
General Hospital
251d
Cleared
Sep 23, 1992
LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE
Strato Medical Corp.
General Hospital
168d
Cleared
Sep 21, 1992
CLAVE CONNECTOR
Icu Medical, Inc.
General Hospital
284d
Cleared
Sep 02, 1992
SOLUTION ADMINISTRATION SET
Douglas Medical Products Corp.
General Hospital
163d
Cleared
Jul 30, 1992
MERIT ADMINISTRATION SET
Merit Medical Systems, Inc.
General Hospital
224d
Cleared
Jun 04, 1992
CONTINU-FLO(R) SOLUTION SET
Baxter Healthcare Corp
General Hospital
55d
Cleared
May 15, 1992
INJECTION SITE WITH LUER LOCK
Baxter Healthcare Corp
General Hospital
137d
Cleared
May 08, 1992
RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET
Ballard Medical Products
General Hospital
177d
Cleared
Mar 23, 1992
8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET
Baxter Healthcare Corp
General Hospital
38d
Cleared
Mar 12, 1992
3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES
Baxter Healthcare Corp
General Hospital
104d
Cleared
Feb 11, 1992
INJECTION CAP
Cp Medical
General Hospital
200d
Cleared
Jan 22, 1992
ANGIOGRAPHIC FLUSH SYSTEM
E-Z-Em, Inc.
General Hospital
131d
Cleared
Jan 10, 1992
MORSE ANESTHESIA
North American Instrument Corp.
General Hospital
416d
Cleared
Jan 09, 1992
ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM
E-Z-Em, Inc.
General Hospital
121d
Cleared
Nov 27, 1991
NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE
Baxter Healthcare Corp
General Hospital
78d
Cleared
Oct 21, 1991
8000 SERIES VOLUMETRIC PUMP SOLUTION SET
Baxter Healthcare Corp
General Hospital
40d
Cleared
Sep 23, 1991
3 PORT ADAPTER
Baxter Healthcare Corp
General Hospital
39d
Cleared
Sep 11, 1991
VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE
Baxter Healthcare Corp
General Hospital
120d