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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 K212908
Device Name EmboTrap II Revascularization Device, 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 Received09/13/2021
Decision Date 10/13/2021
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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