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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 K200634
Device Name Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
Applicant
Arrow International Inc.
16 Elizabeth Drive
Chelmsford,  MA  01824
Applicant Contact Apurva N. Gokhale
Correspondent
Arrow International Inc.
16 Elizabeth Drive
Chelmsford,  MA  01824
Correspondent Contact Apurva N. Gokhale
Regulation Number870.3535
Classification Product Code
DSP  
Date Received03/10/2020
Decision Date 04/09/2020
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
Recalls CDRH Recalls
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