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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 K201998
Device Name JETi AIO Peripheral Thrombectomy System
Applicant
Walk Vascular, LLC
17171 Daimler St.
Irvine,  CA  92614
Applicant Contact David Look
Correspondent
Walk Vascular, LLC
17171 Daimler St.
Irvine,  CA  92614
Correspondent Contact Paul Gasser
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received07/20/2020
Decision Date 11/17/2020
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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