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
Sep 18, 1996
FLEX NEEDLE
Lighthouse Medical, Inc.
General Hospital
187d
Cleared
Sep 16, 1996
BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102
Biomedix, Inc.
General Hospital
122d
Cleared
Sep 13, 1996
VENIPUNCTURE KIT
Miller Products and Services
General Hospital
37d
Cleared
Aug 28, 1996
SAFE MATE I.V. EXTENSION SETS
Biological & Environmental Control Laboratories
General Hospital
41d
Cleared
Aug 28, 1996
SAFE MATE I.V. FLUID DELIVERY SETS
Biological & Environmental Control Laboratories
General Hospital
41d
Cleared
Aug 01, 1996
FLUID ADMINISTRATION SET - CONTRAST MANAGER
Merit Medical Systems, Inc.
General Hospital
84d
Cleared
Jul 10, 1996
I.V. ADMINISTRATION SETS
Medical Associates Network, Inc.
General Hospital
197d
Cleared
Jul 03, 1996
STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
Strato/Infusaid, Inc.
General Hospital
156d
Cleared
Jun 26, 1996
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE
Baxter Healthcare Corp
General Hospital
69d
Cleared
Jun 21, 1996
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
Baxter Healthcare Corp
General Hospital
84d
Cleared
May 29, 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
Abbott Laboratories
General Hospital
267d
Cleared
May 15, 1996
V2 INJECTION SITE
B.Braun Medical, Inc.
General Hospital
160d
Cleared
May 15, 1996
BEC NEEDLELESS INJECTION SITE
Biological & Environmental Control Laboratories
General Hospital
37d
Cleared
May 06, 1996
SNAPDOSE DEVICE
Abbott Laboratories
General Hospital
161d
Cleared
May 06, 1996
POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133
Medtronic Minimed
General Hospital
18d
Cleared
Apr 23, 1996
FREE FLOW SAFETY DEVICE
Migada, Inc.
General Hospital
186d
Cleared
Apr 04, 1996
IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
Y
General Hospital
76d
Cleared
Mar 21, 1996
MAXCESS NEEDLE FREE CONNECTOR (8200)
Solopak Medical Products, Inc.
General Hospital
34d
Cleared
Feb 26, 1996
ANGIOFLUSH II FLUID MANAGEMENT SYSTEM
AngioDynamics, Inc.
General Hospital
195d
Cleared
Feb 22, 1996
POLYFIN QR SUBCUTANEOUS INFUSION SET
Medtronic Minimed
General Hospital
115d
Cleared
Feb 21, 1996
WINGED & SUBCUTANEOUS INFUSION SETS
Distronic Sterile Products, Inc.
General Hospital
65d
Cleared
Feb 21, 1996
VENTED SOLUTION SET
Distronic Sterile Products, Inc.
General Hospital
64d
Cleared
Feb 16, 1996
NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
Critical Device Corp.
General Hospital
240d
Cleared
Feb 07, 1996
VLV SA.EF INFUSION PORT EXTENSION SETS
Vlv Associates, Inc.
General Hospital
48d