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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 K190101
Device Name UltraFlex IAB
Applicant
Arrow International, Inc.
16 Elizabeth Drive
Chelmsford,  MA  01824
Applicant Contact Niyati Boghani
Correspondent
Arrow International, Inc.
16 Elizabeth Drive
Chelmsford,  MA  01824
Correspondent Contact Niyati Boghani
Regulation Number870.3535
Classification Product Code
DSP  
Date Received01/22/2019
Decision Date 06/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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