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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Carotid Catheter For Embolic Capture
510(k) Number K230402
Device Name ENROUTE® Transcarotid Neuroprotection System
Applicant
Silk Road Medical
1213 Innsbruck Dr.
Sunnyvale,  CA  94089
Applicant Contact Denise Aycox
Correspondent
Silk Road Medical
1213 Innsbruck Dr.
Sunnyvale,  CA  94089
Correspondent Contact Denise Aycox
Regulation Number870.1250
Classification Product Code
NTE  
Date Received02/15/2023
Decision Date 04/11/2023
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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