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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 K233924
Device Name EMBOGUARD Balloon Guide Catheter
Applicant
Neuravi Limited
Block 3
Ballybrit Business Park
Galway,  IE
Applicant Contact Niall Fox
Correspondent
Neuravi Limited
Block 3
Ballybrit Business Park
Galway,  IE
Correspondent Contact Niall Fox
Regulation Number870.1250
Classification Product Code
QJP  
Date Received12/13/2023
Decision Date 04/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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