Medical Device Manufacturer · US , Reading , PA

Arrow International, Inc. - FDA 510(k) Cleared Devices

19 submissions · 17 cleared · Since 2003

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

FDA 510(k) Regulatory Record - Arrow International, Inc. General Hospital ✕

6 devices

1-6 of 6

Cleared Apr 26, 2013

CG+ ARROW PICC POWERED BY ARROW VPS STYLET

General Hospital · 28d

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

Cleared Jan 15, 2008

PRESSURE INJECTABLE PICC

General Hospital · 36d

Cleared Aug 30, 2007

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS...

General Hospital · 86d

Cleared Aug 24, 2006

ARROW PRESSURE INJECTABLE PICC

General Hospital · 107d