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
Mar 23, 1994
EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30
Puritas Health Care, Inc.
General Hospital
76d
Cleared
Feb 22, 1994
SAFE CONNECTOR
Icu Medical, Inc.
General Hospital
32d
Cleared
Feb 09, 1994
REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG
Pharmacia Deltec, Inc.
General Hospital
212d
Cleared
Jan 21, 1994
0.22 MICRON FINAL FILTER WITH EXTENSION TUBE
Puritas Health Care, Inc.
General Hospital
63d
Cleared
Jan 14, 1994
SOLUTION SET WITH .2 MICRON FILTER
Douglas Medical Products Corp.
General Hospital
330d
Cleared
Jan 10, 1994
EZ ADMINISTRATION SET
Y
General Hospital
287d
Cleared
Jan 07, 1994
3 LEAD CONNECTOR
Douglas Medical Products Corp.
General Hospital
277d
Cleared
Jan 07, 1994
SUBCUTANEOUS INFUSION SET
Douglas Medical Products Corp.
General Hospital
219d
Cleared
Dec 21, 1993
IN-LINE BURETTE SET
Douglas Medical Products Corp.
General Hospital
260d
Cleared
Dec 14, 1993
HUBER NEEDLE INFUSION SET
Douglas Medical Products Corp.
General Hospital
195d
Cleared
Nov 29, 1993
INJECTION SITE
3M Health Care, Ltd.
General Hospital
193d
Cleared
Nov 03, 1993
ENERGIZED CONTAINER SYSTEM
Abbott Laboratories
General Hospital
372d
Cleared
Oct 14, 1993
AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET
3M Avi, Inc.
General Hospital
888d
Cleared
Oct 12, 1993
IVAC NEEDLELESS INJECTION VALVE
Y
General Hospital
525d
Cleared
Sep 03, 1993
DURHAM
Intl. Medical, Inc.
General Hospital
220d
Cleared
Sep 03, 1993
DURHAM
Intl. Medical, Inc.
General Hospital
220d
Cleared
Aug 28, 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
Baxter Healthcare Corp
General Hospital
310d
Cleared
Aug 11, 1993
EXEL HUBER INFUSION SET ROTATING WING
Exel Intl.
General Hospital
251d
Cleared
Aug 03, 1993
BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
C.R. Bard, Inc.
General Hospital
301d
Cleared
Aug 03, 1993
LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER
Douglas Medical Products Corp.
General Hospital
280d
Cleared
Jul 30, 1993
IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL
Y
General Hospital
287d
Cleared
Jul 30, 1993
REPLACEMENT CAP
Douglas Medical Products Corp.
General Hospital
162d
Cleared
Jul 27, 1993
DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT
Douglas Medical Products Corp.
General Hospital
231d
Cleared
Jul 20, 1993
BAXTER SOLUTION ADMINISTRATION SETS
Baxter Healthcare Corp
General Hospital
302d