Arrow International, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Arrow International, Inc. - FDA 510(k) Cleared Devices
Recent clearances: AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP, Arrow FiberOptix Intra-Aortic Balloon Catheter Kit, UltraFlex IAB
19
Total
17
Cleared
0
Denied
Arrow International, Inc. has 17 FDA 510(k) cleared medical devices. Based in Reading, US.
Historical record: 17 cleared submissions from 2003 to 2020.
Browse the FDA 510(k) cleared devices submitted by Arrow International, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Arrow International, Inc.
19 devices
Cleared
May 27, 2020
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
Cardiovascular
30d
Cleared
Apr 09, 2020
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
Cardiovascular
30d
Cleared
Jun 28, 2019
UltraFlex IAB
Cardiovascular
157d
Cleared
Jun 13, 2019
Fiberoptix IAB
Cardiovascular
140d
Cleared
Mar 31, 2017
AC3 Series IABP System
Cardiovascular
175d
Cleared
Jul 07, 2014
VECTORFLOW
Gastroenterology & Urology
74d
Cleared
May 10, 2013
NEXTSTEP RETROGRADE
Gastroenterology & Urology
105d
Cleared
Apr 26, 2013
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
General Hospital
28d
Cleared
Dec 21, 2012
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
Anesthesiology
108d
Cleared
Aug 28, 2012
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
Anesthesiology
48d
Cleared
Jun 21, 2012
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
General Hospital
227d
Cleared
Jun 27, 2008
PRESSURE INJFECTABLE PICC
General Hospital
115d