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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 K220866
Device Name EKOS+ Endovascular Device
Applicant
Boston Scientific
Two Scimed Place
Maple Grove,  MN  55311
Applicant Contact Daniel Root
Correspondent
Boston Scientific
Two Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Daniel Root
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received03/25/2022
Decision Date 04/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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