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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 K214048
FOIA Releasable 510(k) K214048
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 Received12/27/2021
Decision Date 09/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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