Arrow International, Inc. - FDA 510(k) Cleared Devices
19
Total
17
Cleared
0
Denied
FDA 510(k) cleared devices by Arrow International, Inc. Cardiovascular ✕
6 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
Oct 15, 2004
SILICONE COATED GUIDEWIRE
Cardiovascular
109d