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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous, neurovasculature
510(k) Number K233648
Device Name Millipede 088 Access Catheter
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
QJP  
Date Received11/14/2023
Decision Date 12/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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