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
Oct 17, 2012
NIPRO SAFE TOUCH HUBER INFUSION SET
Nipro Medical Corporation
General Hospital
330d
Cleared
Sep 07, 2012
ZYNO MEDICAL ADMINISTRATION SET
Zyno Medical, LLC
General Hospital
185d
Cleared
Jul 06, 2012
SAFETY SUBCUTANEOUS TISSUE INFUSION SET
Multi Med
General Hospital
165d
Cleared
Jun 29, 2012
FLOWEASE [SUBCUTANEOUS] INFUSION SET
Baxter Healthcare Corp
General Hospital
80d
Cleared
Jun 29, 2012
INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
Baxter Healthcare Corporation
General Hospital
25d
Cleared
Jun 28, 2012
MED-RX PATIENT DELIVERY SET
Benlan, Inc.
General Hospital
143d
Cleared
Jun 21, 2012
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
Hospira, Inc.
General Hospital
77d
Cleared
Jun 08, 2012
Q-FLO CLOSED MALE LUER CONNECTOR
Us Fusion, LLC. Dba Truecare Biomedix-USA
General Hospital
14d
Cleared
May 30, 2012
NERIA MULTI SUBCUTANEOUS INFUSION SET
Unomedical Devices S.A DE C.V.
General Hospital
112d
Cleared
May 22, 2012
NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE
Baxter Healthcare Corporation - Renal Division
General Hospital
98d
Cleared
May 04, 2012
HLIC NEEDLE-LESS VALVE
Health Line International Corporation
General Hospital
71d
Cleared
May 02, 2012
PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER
Perouse Medical
General Hospital
96d
Cleared
Apr 20, 2012
ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
Unomedical A/S Infusion Devices
General Hospital
29d
Cleared
Apr 18, 2012
NEXUS TKO-6, LUER-ACTIVATED DEVICE
Nexus Medical, LLC
General Hospital
153d
Cleared
Apr 11, 2012
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...
Rx Devices, LLC
General Hospital
266d
Cleared
Mar 30, 2012
ARISURE NEUTRAL VALVE
Yukon Medical, LLC
General Hospital
14d
Cleared
Jan 12, 2012
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
Hospira, Inc.
General Hospital
28d
Cleared
Dec 23, 2011
MED-RX EXTENSION SET WITH T-CONNECTOR
Benlan, Inc.
General Hospital
87d
Cleared
Nov 26, 2011
CYTOGUARD(TM) CLOSED LUER CONNECTOR
B.Braun Medical, Inc.
General Hospital
78d
Cleared
Oct 20, 2011
VANISHPOINT BLOOD COLLECTION SET
Retractable Technologies, Inc.
General Hospital
51d
Cleared
Oct 18, 2011
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
Baxter Healthcare Corporation
General Hospital
15d
Cleared
Sep 29, 2011
TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET
Us Infusion Dba Truecare Biomedix
General Hospital
139d
Cleared
Jul 21, 2011
INFUSION SET FOR POWERPICC SOLO 2 CATHETER
C.R. Bard, Inc.
General Hospital
331d
Cleared
Jun 23, 2011
CENTURION PRESSURE INJECTABLE EXTENSION SET
Centurion Medical Products Corporation
General Hospital
199d