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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 K162820
Device Name AC3 Series IABP System
Applicant
ARROW INTERNATIONAL, INC.
16 ELIZABETH DR
Chelmsford,  MA  01824
Applicant Contact Alifiya Jagmag
Correspondent
ARROW INTERNATIONAL, INC.
16 ELIZABETH DR
Chelmsford,  MA  01824
Correspondent Contact Alifiya Jagmag
Regulation Number870.3535
Classification Product Code
DSP  
Date Received10/07/2016
Decision Date 03/31/2017
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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