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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K193197
Device Name QuickClear Mechanical Thrombectomy System
Applicant
Volcano Atheromed, Inc.
1530 O'Brien Dr.
Suite A
Menlo Park,  CA  94025
Applicant Contact Anna Gloria Stephen
Correspondent
Volcano Atheromed, Inc.
1530 O'Brien Dr.
Suite A
Menlo Park,  CA  94025
Correspondent Contact Anna Gloria Stephen
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received11/20/2019
Decision Date 04/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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