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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 K232524
Device Name Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Applicant
Perfuze Ltd.
Unit 6, Galway Business Park
Dangan
Galway,  IE H91 W7CP
Applicant Contact Anne-Marie Gannon
Correspondent
Perfuze Ltd.
Unit 6, Galway Business Park
Dangan
Galway,  IE H91 W7CP
Correspondent Contact Anne-Marie Gannon
Regulation Number870.1250
Classification Product Code
NRY  
Date Received08/18/2023
Decision Date 10/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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