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 B.Braun Medical, Inc..
1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
Cleared
Aug 30, 1994
BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
195d
Cleared
Jul 29, 1994
PROVIDER PUMP SET W/INFUSION CARTRIDGE
Abbott Laboratories
General Hospital
317d
Cleared
Jun 09, 1994
ENERGIZED DRUG CONTAINER SYSTEM
Abbott Laboratories
General Hospital
288d
Cleared
May 05, 1994
CONTROL-A-FLO(TM) REGULATOR
Baxter Healthcare Corp
General Hospital
71d
Cleared
Mar 28, 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
Abbott Laboratories
General Hospital
263d
Cleared
Nov 03, 1993
ENERGIZED CONTAINER SYSTEM
Abbott Laboratories
General Hospital
372d
Cleared
Aug 28, 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
Baxter Healthcare Corp
General Hospital
310d
Cleared
Aug 03, 1993
BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
C.R. Bard, Inc.
General Hospital
301d
Cleared
Jul 20, 1993
BAXTER SOLUTION ADMINISTRATION SETS
Baxter Healthcare Corp
General Hospital
302d
Cleared
Jun 18, 1993
INTERLINK(TM) INJECTION SITE
Baxter Healthcare Corp
General Hospital
248d
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
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
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
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
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
May 18, 1990
IN-LINE VIAL CONNECTION SITE
Baxter Healthcare Corp
General Hospital
80d