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
May 21, 1984
SYRINGE ADDITIVE IV ADMIN. SETS
Quest Medical, Inc.
General Hospital
49d
Cleared
Apr 05, 1984
HARVARD ANTI-REFLUX Y-SET
C.R. Bard, Inc.
General Hospital
42d
Cleared
Mar 30, 1984
QUIK LOK
Abbott Laboratories
General Hospital
32d
Cleared
Mar 06, 1984
LOPEZ LOCK
Icu Medical, Inc.
General Hospital
43d
Cleared
Feb 21, 1984
NITROGLYCERIN I.V. ADMINISTRATION SET
Critikon Company, LLC
General Hospital
98d
Cleared
Jan 30, 1984
INTRAVENOUS FILTER SET
Tri-Med, Inc.
General Hospital
77d
Cleared
Jan 30, 1984
CONTINU-FLO SOLUTION ADMIN. 2C9102
Travenol Laboratories, S.A.
General Hospital
53d
Cleared
Dec 29, 1983
SOLUTION ADMIN. SET 2C9096 W/10 PVC
Travenol Laboratories, S.A.
General Hospital
169d
Cleared
Dec 27, 1983
VENOSET MULTI-MED PIGGYBACK W/IVEX-2
Abbott Laboratories
General Hospital
62d
Cleared
Dec 22, 1983
VENOSET MULTI MED DUAL RATE PIGGYBACK
Abbott Laboratories
General Hospital
57d
Cleared
Nov 07, 1983
INFUSION SET-52-05-1 20 DROPS-MI VOL
Y
General Hospital
61d
Cleared
Nov 07, 1983
UNIVERSAL VENTED & NON/VOLUME INFUS-
Y
General Hospital
61d
Cleared
Nov 03, 1983
INTRAVASCULAR ADMINISTRATION SET
Gish Biomedical, Inc.
General Hospital
57d
Cleared
Sep 12, 1983
INFUSION SETS #'S 124 & 142 PERSONAL
Pacesetter Systems
General Hospital
130d
Cleared
Aug 24, 1983
STERILE IV SET 4 SIZES
Abco Dealers, Inc.
General Hospital
40d
Cleared
Aug 12, 1983
VENIPUNCTURE VALVE
Abbott Laboratories
General Hospital
43d
Cleared
Jun 08, 1983
SOLUTION ADMIN. SETS W/FLASHBALL
Travenol Laboratories, S.A.
General Hospital
47d
Cleared
Apr 14, 1983
SPECIALTY SET MODEL IV7A01
Valleylab, Inc.
General Hospital
24d
Cleared
Mar 24, 1983
INFUSION PUMP RETROGRADE EXTEN. AS 715
Narco Scientific
General Hospital
23d
Cleared
Mar 01, 1983
PORT-LOCK
Norfolk Medical Products, Inc.
General Hospital
70d
Cleared
Feb 09, 1983
MINILOOP I.V. CONNECTORS & ADAPTOR
Medex, Inc.
General Hospital
22d
Cleared
Feb 07, 1983
MINILOOP DISPOS. IV CONNECTORS ADAPT.
Medex, Inc.
General Hospital
20d
Cleared
Jan 12, 1983
DOSIMETRIC RELEASE PROGRAM - ADMIN. SET
Cutter Laboratories, Inc.
Chemistry
76d
Cleared
Nov 30, 1982
ACCUSET ADMINISTRATION SET
Imed Corp.
General Hospital
21d