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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
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