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 28, 2015
Imed Technology Intravascular Administration Set, Imed Technology Extension Set
Imed Technology, Inc.
General Hospital
90d
Cleared
Apr 28, 2015
BD FlowSmart Set
Becton, Dickinson Company
General Hospital
105d
Cleared
Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
Baxter Healthcare Corporation
General Hospital
15d
Cleared
Mar 04, 2015
Hospira Blood Set
Hospira, Inc.
General Hospital
128d
Cleared
Feb 25, 2015
Hospira Primary Sets
Hospira, Inc.
General Hospital
128d
Cleared
Feb 19, 2015
BUSSE EXTENSION SET
Busse Hospital Disposables
General Hospital
279d
Cleared
Jan 16, 2015
All Safe Huber Safety Infusion Set
Nexus Medical, LLC
General Hospital
123d
Cleared
Jan 15, 2015
IV Administration
Hospira, Inc.
General Hospital
121d
Cleared
Jan 09, 2015
Extension Sets
Hospira, Inc.
General Hospital
87d
Cleared
Dec 08, 2014
Hospira Extension Set
Hospira, Inc.
General Hospital
101d
Cleared
Dec 05, 2014
IV ADMINISTRATION SET WITH HAND PUMP
B.Braun Medical, Inc.
General Hospital
247d
Cleared
Nov 25, 2014
Hospira Primary Sets
Hospira, Inc.
General Hospital
92d
Cleared
Nov 20, 2014
MaxZero Administration Sets
Care Fusion
General Hospital
10d
Cleared
Oct 02, 2014
PADI-LOCK
Padi-Lock, LLC
General Hospital
146d
Cleared
Sep 19, 2014
Extension Set with BD Q-Syte Luer Access Split Septum
Acacia, Inc.
General Hospital
11d
Cleared
Aug 29, 2014
SELEC-3 I.V.ADMINISTRATION SET
Biomedix, Inc.
General Hospital
28d
Cleared
Aug 25, 2014
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
B.Braun Medical, Inc.
General Hospital
28d
Cleared
Aug 18, 2014
SOLUTION SET/EXTENSION SET
Baxter Healthcare Corporation
General Hospital
25d
Cleared
Aug 05, 2014
INTRAVASCULAR ADMINISTRATION SET
Delta Med Spa
General Hospital
194d
Cleared
Aug 05, 2014
SAPPHIRE ADMINISTRATION SET
Q Core Medical , Ltd.
General Hospital
29d
Cleared
Jun 12, 2014
TEVADAPTOR
Teva Medical Ltd., Migada Plant
General Hospital
24d
Cleared
May 22, 2014
NEXUS NIS-6P LUER ACTIVATED DEVICE
Nexus Medical, LLC
General Hospital
203d
Cleared
May 15, 2014
INFUSET FLOW CONTROL EXTENSION SET
Emed Technologies Corporation
General Hospital
118d
Cleared
May 07, 2014
CARESITE LUER ACCESS DEVICE
B.Braun Medical, Inc.
General Hospital
89d