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
Jan 06, 1998
V3 VALVE
B.Braun Medical, Inc.
General Hospital
64d
Cleared
Dec 17, 1997
PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET
Globe Ent., Inc.
General Hospital
138d
Cleared
Dec 17, 1997
PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY
Globe Ent., Inc.
General Hospital
138d
Cleared
Dec 17, 1997
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE
Sims Deltec, Inc.
General Hospital
56d
Cleared
Dec 16, 1997
EXEL I.V. ADMINISTRATION SET
Exel Intl.
General Hospital
469d
Cleared
Nov 17, 1997
POSITIVE PRESSURE CONNECTOR
Icu Medical, Inc.
General Hospital
84d
Cleared
Oct 02, 1997
MEDCORP FLOW I.V. REGULATOR EXTENSION SET
Medcorp Intl.
General Hospital
197d
Cleared
Oct 02, 1997
AMSINO I.V. ADMINISTRATION SET
Amsino Intl., Inc.
General Hospital
44d
Cleared
Oct 01, 1997
CORE RESISTANT HUBER INFUSION SETS
Icu Medical, Inc.
General Hospital
72d
Cleared
Sep 29, 1997
SA-EF MULTI-LUMEN EXTENSION SET
Vlv Associates, Inc.
General Hospital
49d
Cleared
Sep 18, 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
Nipro Medical Corp.
General Hospital
77d
Cleared
Sep 18, 1997
PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS
Quality System Consulting
General Hospital
73d
Cleared
Sep 08, 1997
DYE STOP AND SAVE - QUICKFILL
Shepherd Laboratories, Inc.
General Hospital
129d
Cleared
Sep 02, 1997
SMART SET
Top Spins, Inc.
General Hospital
56d
Cleared
Aug 26, 1997
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
P/L Biomedical
General Hospital
81d
Cleared
Aug 18, 1997
ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER
Biological & Environmental Control Laboratories
General Hospital
116d
Cleared
Jul 16, 1997
NEEDLE-FREE VALVED CONNECTOR AND CAP
Bmw Medical, Inc.
General Hospital
252d
Cleared
Jun 27, 1997
LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
Abbott Mfg., Inc.
General Hospital
81d
Cleared
Jun 24, 1997
VENTED I.V. SET
Jms Co., Ltd.
General Hospital
189d
Cleared
Jun 24, 1997
CLAVE CONNECTOR
Icu Medical, Inc.
General Hospital
106d
Cleared
Jun 06, 1997
CONTINU-FLO SOLUTION SET
Baxter Healthcare Corp
General Hospital
29d
Cleared
Jun 05, 1997
GORE IRRIGATION SET
W.L. Gore & Associates, Inc.
General Hospital
238d
Cleared
Jun 04, 1997
TAMARYN I.V. FLOW REGULATOR EXTENSION SET
Tamaryn Medical Systems, Inc.
General Hospital
72d
Cleared
May 06, 1997
SAFE-CONNECT I.V. SET
Faulding Medical Device Co.
General Hospital
55d