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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Carotid Catheter For Embolic Capture
510(k) Number K180023
Device Name WIRION
Applicant
Gardia Medical , Ltd.
Haeshel 2
Caesarea,  IL 3088900
Applicant Contact Vardit Segal
Correspondent
Gardia Medical , Ltd.
Haeshel 2
Caesarea,  IL 3088900
Correspondent Contact Vardit Segal
Regulation Number870.1250
Classification Product Code
NTE  
Date Received01/03/2018
Decision Date 03/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01042444
NCT01783639
NCT02780349
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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