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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 K173452
Device Name EmboTrap ll Revascularization Device
Applicant
Neuravi, Ltd.
Block 3
Ballybrit Business Park
Galway,  IE
Applicant Contact Mairsil Claffey
Correspondent
Neuravi, Ltd.
Block 3
Ballybrit Business Park
Galway,  IE
Correspondent Contact Mairsil Claffey
Regulation Number870.1250
Classification Product Code
NRY  
Date Received11/06/2017
Decision Date 05/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02488915
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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