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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 K240711
Device Name Zipline Access Catheter
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
QJP  
Date Received03/15/2024
Decision Date 10/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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