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 04, 1999
SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B
Msr, Inc.
General Hospital
43d
Cleared
Jan 20, 1999
ROWE DUAL-CHECK VALVE
Cook, Inc.
General Hospital
128d
Cleared
Jan 20, 1999
MPS GRAVITY FLOW CONTROL SET
Critical Device Corp.
General Hospital
76d
Cleared
Dec 16, 1998
I.V. EXTENSION SET OR I.V. ADMINISTRATION SET
Integra Biotechnical, LLC
General Hospital
105d
Cleared
Sep 04, 1998
COLLEAGUE PUMP SYRINGE ADAPTER SET
Baxter Healthcare Corp
General Hospital
35d
Cleared
Aug 24, 1998
MPS FIXED FLOW RATE SET
Medical Product Specialists
General Hospital
31d
Cleared
Aug 17, 1998
SOLUTION ADMINISTRATION SET
Baxter Healthcare Corp
General Hospital
88d
Cleared
Jul 28, 1998
HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y
Venusa , Ltd.
General Hospital
76d
Cleared
Jul 21, 1998
MPS HUBER NEEDLE EXTENSION SET
Medical Product Specialists
General Hospital
41d
Cleared
Jul 21, 1998
CONTRAST CONTROL DEVICE
Medex, Inc.
General Hospital
35d
Cleared
Jun 29, 1998
MANAN BLUNT NEEDLE
Manan Medical Products, Inc.
General Hospital
74d
Cleared
Jun 18, 1998
NFC NEEDLEFREE Y-SITE, MODEL 69970
Filtertek, Inc.
General Hospital
49d
Cleared
Jun 18, 1998
NFC NEEDLEFREE CONNECTOR MODEL 69900
Filtertek, Inc.
General Hospital
49d
Cleared
Jun 16, 1998
STABLE FLOW
Cmed
General Hospital
77d
Cleared
May 29, 1998
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES
Venetec Intl., Inc.
General Hospital
73d
Cleared
May 28, 1998
IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
Venetec Intl., Inc.
General Hospital
72d
Cleared
May 21, 1998
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
Baxter Healthcare Corp
General Hospital
164d
Cleared
Apr 27, 1998
EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
Sims Deltec, Inc.
General Hospital
69d
Cleared
Apr 22, 1998
DUAL LUER LOCK CAP
Baxter Healthcare Corp
General Hospital
12d
Cleared
Mar 11, 1998
6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT
Catheter Innovations, Inc.
General Hospital
56d
Cleared
Mar 09, 1998
NP MEDICAL CAPLESS LUER ACTIVATED VALVE
Np Medical, Inc.
General Hospital
146d
Cleared
Feb 02, 1998
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
Medtronic Minimed
General Hospital
89d
Cleared
Jan 23, 1998
MCKINLEY OUTBOUND-2 SYSTEM
Mckinley, Inc.
General Hospital
249d
Cleared
Jan 09, 1998
SMARTVALVE
Icu Medical, Inc.
General Hospital
31d