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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K211697
Device Name Esperance Aspiration Catheter System
Applicant
Wallaby Medical
22901 Mill Creek Dr.
Laguna Hills,  CA  92653
Applicant Contact Nathaniel Knock
Correspondent
Wallaby Medical
22901 Mill Creek Dr.
Laguna Hills,  CA  92653
Correspondent Contact Nathaniel Knock
Regulation Number870.1250
Classification Product Code
NRY  
Date Received06/03/2021
Decision Date 11/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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