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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 K161786
Device Name ClearLumen II Thrombectomy System
Applicant
Walk Vascular, LLC
17171 Daimler St.
Irvine,  CA  92614
Applicant Contact David Look
Correspondent
Paul Gasser
13612 Rushmore Ln.
Santa Ana,  CA  92705
Correspondent Contact Paul Gasser
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received06/29/2016
Decision Date 10/18/2016
Decision SE - With Limitations (SESU)
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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