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 30, 1996
VENIPUNCTURE KIT
Winfield Industries
General Hospital
102d
Cleared
Jan 26, 1996
ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET
Arrow Intl., Inc.
General Hospital
169d
Cleared
Jan 23, 1996
I.V. ADMINISTRATION SET CONNECTING DEVICE
Sierra Medical Devices
General Hospital
699d
Cleared
Jan 23, 1996
EXTENSION SET WITH CHECK VALVE
Distronic Sterile Products, Inc.
General Hospital
84d
Cleared
Dec 15, 1995
SIMS DELTEC ANTI-SIPHON VALVE
Sims Deltec, Inc.
General Hospital
52d
Cleared
Nov 29, 1995
ICU EXTENSION KIT
Icu Medical, Inc.
General Hospital
41d
Cleared
Nov 21, 1995
LOW PROFILE SAFSITE Y-SITE
B.Braun Medical, Inc.
General Hospital
81d
Cleared
Oct 24, 1995
LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG
Abbott Laboratories
General Hospital
84d
Cleared
Sep 27, 1995
IVAC BALL VALCE ADMIN. SETS
Y
General Hospital
79d
Cleared
Sep 21, 1995
INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)
Medex, Inc.
General Hospital
136d
Cleared
Sep 15, 1995
PLASTIC BLUNT CANNULA
Marquette Medical, Inc.
General Hospital
80d
Cleared
Aug 24, 1995
VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES
Imed Corp.
General Hospital
219d
Cleared
Aug 18, 1995
FIXED FLOW RATE GRAVITY ADMINISTRATION SETS
I-Flow Corp.
General Hospital
63d
Cleared
Jul 27, 1995
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
Baxter Healthcare Corp
General Hospital
86d
Cleared
Jul 19, 1995
ADMINISTRATION SETS WITH BALL FLOAT
Imed Corp.
General Hospital
86d
Cleared
Jul 14, 1995
FILTERED EXTENSION SETS
B. Braun of America, Inc.
General Hospital
389d
Cleared
Jun 14, 1995
SMARTFLOW I ADMINISTRATION SET
River Medical, Inc.
General Hospital
226d
Cleared
May 31, 1995
E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS
Becton Dickinson Vascular Access, Inc.
General Hospital
30d
Cleared
Apr 10, 1995
LOW VOLUME MULTIPORT
B. Braun of America, Inc.
General Hospital
251d
Cleared
Mar 14, 1995
DESERET(R) I.V. LOOP AND DESERET (R) J LOOP
Becton Dickinson Vascular Access, Inc.
General Hospital
48d
Cleared
Mar 14, 1995
DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER
Becton Dickinson Vascular Access, Inc.
General Hospital
48d
Cleared
Mar 13, 1995
E-Z SET(R) AND MINICATH(R) INFUSION SETS
Becton Dickinson Vascular Access, Inc.
General Hospital
47d
Cleared
Feb 14, 1995
VENTED/NON-VENTED GEMINI ADMINISTRATION SET
Imed Corp.
General Hospital
169d
Cleared
Feb 10, 1995
NU-SITE
Medex, Inc.
General Hospital
184d