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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K193063
Device Name EMBOTRAP III Revascularization Device
Applicant
Neuravi, Ltd.
Block 3, Ballybrit Business Park,
Galway,  IE H91 K5YD
Applicant Contact Niall Fox
Correspondent
Neuravi, Ltd.
Block 3, Ballybrit Business Park,
Galway,  IE H91 K5YD
Correspondent Contact Niall Fox
Regulation Number870.1250
Classification Product Code
NRY  
Date Received11/04/2019
Decision Date 07/14/2020
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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