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FDA 510(k) Applications Submitted by Arrow International Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200634
03/10/2020
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
Arrow International Inc.
K201112
04/27/2020
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
Arrow International Inc.
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