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 01, 1997
SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518
Faulding Medical Device Co.
General Hospital
27d
Cleared
Apr 22, 1997
SAFE-CONNECT I.V. EXTENSION SET
Faulding Medical Device Co.
General Hospital
70d
Cleared
Apr 21, 1997
SMARTSITE ACCESS PIN
Ivac Medical Systems
General Hospital
70d
Cleared
Apr 14, 1997
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
Critical Device Corp.
General Hospital
126d
Cleared
Apr 14, 1997
KIPP MED I.V. MANIFOLD
The Kipp Group
General Hospital
82d
Cleared
Apr 08, 1997
E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
Becton Dickinson Vascular Access, Inc.
General Hospital
75d
Cleared
Apr 02, 1997
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
Baxter Healthcare Corp
General Hospital
56d
Cleared
Apr 02, 1997
MAXCESS NEEDLEFREE - Y- SITE (100713)
Solopak Medical Products, Inc.
General Hospital
29d
Cleared
Mar 27, 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
Nipro Medical Corp.
General Hospital
77d
Cleared
Mar 24, 1997
CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS
Conmedcorp
General Hospital
111d
Cleared
Feb 28, 1997
SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET
Vlv Associates, Inc.
General Hospital
85d
Cleared
Feb 27, 1997
MR EXTENSION SET (001)
University of Michigan
General Hospital
77d
Cleared
Feb 25, 1997
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
Baxter Healthcare Corp
General Hospital
84d
Cleared
Feb 14, 1997
VYGON BIONECTOR WITH EXTENSION SET
Vygon Corp.
General Hospital
134d
Cleared
Feb 10, 1997
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
Critical Device Corp.
General Hospital
73d
Cleared
Jan 30, 1997
POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
Medtronic Minimed
General Hospital
85d
Cleared
Jan 30, 1997
POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
Medtronic Minimed
General Hospital
85d
Cleared
Jan 27, 1997
MODEL D-290P ADMINISTRATION SET
Patient Solutions, Inc.
General Hospital
84d
Cleared
Dec 10, 1996
SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM
Rymed Technologies, Inc.
General Hospital
288d
Cleared
Nov 15, 1996
SAFECONNECT VALVE (CATALOG NO. XXXX)
Faulding Medical Device Co.
General Hospital
330d
Cleared
Nov 08, 1996
MMG MULTI LUMON EXTENSION SET
Mmg Healthcare, Inc.
General Hospital
88d
Cleared
Oct 29, 1996
PRESSURE STOPCOCK/MANIFOLD
Scientific Device Manufacturer, LLC
General Hospital
272d
Cleared
Oct 18, 1996
INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
Baxter Healthcare Corp
General Hospital
85d
Cleared
Oct 18, 1996
DELTEC SUBCUTANEOUS INFUSION SET
Sims Deltec, Inc.
General Hospital
77d