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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 K253590
Device Name Millipede System
Applicant
Perfuze, Ltd.
Unit 6, Galway Business Park
Dangan
Galway,  IE H91W7CP
Applicant Contact Anne-Marie Gannon
Correspondent
Perfuze, Ltd.
Unit 6, Galway Business Park
Dangan
Galway,  IE H91W7CP
Correspondent Contact Anne-Marie Gannon
Regulation Number870.1250
Classification Product Code
NRY  
Date Received11/17/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Clinical Trials NCT05714501
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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