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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K201112
Device Name AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
Applicant
Arrow International Inc.
16 Elizabeth Drive
Chelmsford,  MA  01824
Applicant Contact Shajunath Nirupama
Correspondent
Arrow International Inc.
16 Elizabeth Drive
Chelmsford,  MA  01824
Correspondent Contact Shajunath Nirupama
Regulation Number870.3535
Classification Product Code
DSP  
Date Received04/27/2020
Decision Date 05/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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