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Arrow International, Inc.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories1
Latest FDA decision2020-05-27
TypeNumberDevice NameCodeDateActions
510(k) K201112 AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSP2020-05-27 View
510(k) K200634 Arrow FiberOptix Intra-Aortic Balloon Catheter KitDSP2020-04-09 View
510(k) K190101 UltraFlex IABDSP2019-06-28 View
510(k) K190117 Fiberoptix IABDSP2019-06-13 View
510(k) K162820 AC3 Series IABP SystemDSP2017-03-31 View
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