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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
Predetermined Change
Control Plan Authorized		 No
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