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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mechanical thrombolysis catheter
510(k) Number K213422
Device Name EkoSonic Endovascular Device, EKOS+ Endovascular Device
Applicant
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  MN  55311
Applicant Contact Ambreen Athar
Correspondent
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Ambreen Athar
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received10/20/2021
Decision Date 12/14/2021
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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