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 11, 1981
MODELS: 52-01-0, 52-01-1
Y
General Hospital
49d
Cleared
May 29, 1981
VENTED PRIMARY PIGGYBACK VENOSET DUAL
Abbott Laboratories
General Hospital
121d
Cleared
May 27, 1981
NITROGLYCERINE IV SET
Abbott Laboratories
General Hospital
110d
Cleared
Mar 31, 1981
HAEMONETICS 170 Y INFUSION SET
Haemonetics Corp.
General Hospital
47d
Cleared
Oct 03, 1980
DISPOSABLE CONSTRAST DELIVERY SPIKE KIT
Stanco Medical, Inc.
General Hospital
10d
Cleared
Aug 27, 1980
PRIMARY SOLUTION ADMIN. SET-#86-01-0 260
Y
General Hospital
22d
Cleared
Aug 27, 1980
MODEL 86-01-1 260 SOLUTION ADMIN. SET
Y
General Hospital
22d
Cleared
Aug 27, 1980
MODEL 86-21-0 260 SECONDARY MEDICATION
Y
General Hospital
22d
Cleared
Aug 27, 1980
MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD
Y
General Hospital
22d
Cleared
Aug 12, 1980
MCGRAW I.V. ADMINISTRATION SET
American Hospital Supply Corp.
General Hospital
40d
Cleared
Aug 12, 1980
MODEL 72-81-0 UNVENTED SOLUTION ADM. SET
Y
General Hospital
28d
Cleared
May 08, 1980
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
Travenol Laboratories, S.A.
General Hospital
38d
Cleared
Apr 16, 1980
Y-TYPE INFUSION SET (2 LEAD)
Haemonetics Corp.
General Hospital
56d
Cleared
Apr 16, 1980
MCGAW/EPIC I.V. ADMIN. SET
American Hospital Supply Corp.
General Hospital
50d
Cleared
Apr 16, 1980
B-D STASET, I.V. FLOW CONTROLLER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
30d
Cleared
Apr 08, 1980
LOW PLASTICIZER ADMINISTRATION SETS
Travenol Laboratories, S.A.
General Hospital
249d
Cleared
Mar 20, 1980
PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN
Abbott Laboratories
General Hospital
59d
Cleared
Jan 16, 1980
VENTED I.V. SET
Abbott Laboratories
General Hospital
72d
Cleared
Dec 20, 1979
CONTINU-FLO ADMIN. SET CODE 2C/200
Travenol Laboratories, S.A.
General Hospital
10d
Cleared
Oct 26, 1979
ALBUMIN INTRAVENOUS ADMINISTRATION SET
Delmed, Inc.
General Hospital
59d
Cleared
Oct 26, 1979
IV EXTENSION SET SL
Abbott Laboratories
General Hospital
29d
Cleared
Jul 30, 1979
SURFLO INJECTION PLUG
Terumo America, Inc.
General Hospital
35d
Cleared
May 29, 1979
INTRAVASCULAR ADMINISTRATION SET
Y
General Hospital
63d
Cleared
May 04, 1979
CUSTOM TUBING SETS
Norton Performance Plastics Corp.
General Hospital
46d