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 03, 1995
IV BAG PUMP
I-Flow Corp.
General Hospital
353d
Cleared
Jan 31, 1995
CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET
Icu Medical, Inc.
General Hospital
323d
Cleared
Jan 20, 1995
BOLUS DISPENSER
I-Flow Corp.
General Hospital
414d
Cleared
Jan 13, 1995
VERSASAE PLASTIC CANNULA- 11 GAUGE
Imed Corp.
General Hospital
91d
Cleared
Dec 13, 1994
IV ADMINISTRATION SET FPA
Medex, Inc.
General Hospital
106d
Cleared
Oct 04, 1994
PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE
Pharmacia Deltec, Inc.
General Hospital
159d
Cleared
Aug 30, 1994
BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
195d
Cleared
Aug 16, 1994
CHECK VALVE SOLUTION SET
Douglas Medical Products Corp.
General Hospital
144d
Cleared
Aug 10, 1994
IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS
Y
General Hospital
352d
Cleared
Jul 29, 1994
PROVIDER PUMP SET W/INFUSION CARTRIDGE
Abbott Laboratories
General Hospital
317d
Cleared
Jul 14, 1994
SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116
Medtronic Minimed
General Hospital
71d
Cleared
Jun 29, 1994
EXTENSION SET WITH ANTI-SIPHON VALVE
Pharmacia Deltec, Inc.
General Hospital
97d
Cleared
Jun 22, 1994
IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET
Y
General Hospital
118d
Cleared
Jun 09, 1994
ENERGIZED DRUG CONTAINER SYSTEM
Abbott Laboratories
General Hospital
288d
Cleared
May 09, 1994
ISOFLUX IXP FLOW REGULATOR
Ferguson Medical
General Hospital
542d
Cleared
May 09, 1994
ISOFLUX IXZ FLOW REGULATOR
Ferguson Medical
General Hospital
542d
Cleared
May 09, 1994
ISOFLUX IXL FLOW REGULATOR
Ferguson Medical
General Hospital
542d
Cleared
May 05, 1994
CONTROL-A-FLO(TM) REGULATOR
Baxter Healthcare Corp
General Hospital
71d
Cleared
Apr 15, 1994
PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH
Imed Corp.
General Hospital
403d
Cleared
Apr 15, 1994
MEASURED VOLUME SOLUTION ADMINISTRATION SET
Puritas Health Care, Inc.
General Hospital
100d
Cleared
Apr 04, 1994
WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM
Puritas Health Care, Inc.
General Hospital
89d
Cleared
Mar 28, 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
Abbott Laboratories
General Hospital
263d
Cleared
Mar 28, 1994
INFUSION ADMINISTRATION SET
Puritas Health Care, Inc.
General Hospital
82d
Cleared
Mar 23, 1994
I.V. SET (20 DROPS/ML)
Puritas Health Care, Inc.
General Hospital
76d