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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 K231802
Device Name Millipede 088 Access Catheter
Applicant
Perfuze Ltd.
Unit 6, Galway Business Park
Dangan,  IE H91 W7CP
Applicant Contact Anne-Marie Gannon
Correspondent
Perfuze Ltd.
Unit 6, Galway Business Park
Dangan,  IE H91 W7CP
Correspondent Contact Anne-Marie Gannon
Regulation Number870.1250
Classification Product Code
QJP  
Date Received06/20/2023
Decision Date 09/19/2023
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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