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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K152335
Device Name Export Advance Aspiration Catheter
Applicant
Medtronic, Inc.
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact Colleen Mullins
Correspondent
Medtronic, Inc.
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact Colleen Mullins
Regulation Number870.5150
Classification Product Code
DXE  
Date Received08/19/2015
Decision Date 09/18/2015
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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