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
Feb 01, 1990
EXTENSION SET
Westmark, Sterile Packing Systems, Inc. (Sps)
General Hospital
76d
Cleared
Jan 18, 1990
GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK
Pharmacia Deltec, Inc.
General Hospital
76d
Cleared
Jan 11, 1990
AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.
3M Company
General Hospital
79d
Cleared
Dec 06, 1989
VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY
Baxter Healthcare Corp
General Hospital
205d
Cleared
Dec 01, 1989
BLUNT NEEDLE PORT/I.V. PORT
Applied Medical Technologies
General Hospital
81d
Cleared
Oct 25, 1989
REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE
Pharmacia Deltec, Inc.
General Hospital
77d
Cleared
Sep 19, 1989
MEDI-TRACE ACCU-NATE DEVICE
Graphic Controls Corp.
General Hospital
197d
Cleared
Sep 18, 1989
VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000
Baxter Healthcare Corp
General Hospital
123d
Cleared
Sep 12, 1989
IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM
Imed Corp.
General Hospital
43d
Cleared
Aug 25, 1989
MODIFIED MATERIAL USED IN INFUSION T
Quinton, Inc.
General Hospital
87d
Cleared
Jul 24, 1989
KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
The Kendal Co.
General Hospital
105d
Cleared
Jul 24, 1989
KENDALL CURITY EXTENSION TUBES
The Kendal Co.
General Hospital
105d
Cleared
Jun 23, 1989
SURFLO(R) WINGED INFUSION SET
Terumo Medical Corp.
General Hospital
114d
Cleared
Jun 23, 1989
TERUMO SURFLO(R) INJECTION PLUG
Terumo Medical Corp.
General Hospital
112d
Cleared
Jun 08, 1989
EXTENSION SET W/FLOW REGULATOR
Baxter Healthcare Corp
General Hospital
128d
Cleared
May 05, 1989
LOW ADSORPTION ADMINISTRATION SET
3M Company
General Hospital
151d
Cleared
Feb 28, 1989
MONOPLACE HYPERBARIC EXTENSION SET (L 11055)
Abbott Laboratories
General Hospital
151d
Cleared
Feb 24, 1989
CRIS ADAPTER
Y
General Hospital
157d
Cleared
Jan 31, 1989
MODIFIED 7 INCH CONTINUOUS INFUSION SETS
Quinton, Inc.
General Hospital
144d
Cleared
Jan 31, 1989
WINGED INFUSION SET
E-Z-Em, Inc.
General Hospital
40d
Cleared
Jan 24, 1989
STANDARD ADMINISTRATION SETS
3M Company
General Hospital
50d
Cleared
Oct 21, 1988
VALLEYLAB I.V. ADMINISTRATION SETS
Valleylab, Inc.
General Hospital
77d
Cleared
Sep 29, 1988
LECTROSPIRAL
Vygon Corp.
General Hospital
38d
Cleared
Sep 23, 1988
SAFESITE INJECTION SITE AND BLUNT CANNULA
Baxter Healthcare Corp
General Hospital
29d