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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 K262399
Device Name Millipede System
Applicant
Perfuze, Ltd.
Unit 6, Galway Business Park
Dangan
Galway,  IE H91W7CP
Applicant Contact Jeanine O'Donnell
Correspondent
Perfuze, Ltd.
Unit 6, Galway Business Park
Dangan
Galway,  IE H91W7CP
Correspondent Contact Jeanine O'Donnell
Regulation Number870.1250
Classification Product Code
NRY  
Date Received07/14/2026
Decision Date 08/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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