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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 K143570
Device Name WIRION
Applicant
Gardia Medical
2 Ha'Eshel St.
Caesarea,  IL 38900
Applicant Contact OHAD HAAS
Correspondent
Gardia Medical
2 Ha'Eshel St.
Caesarea,  IL 38900
Correspondent Contact OHAD HAAS
Regulation Number870.1250
Classification Product Code
NTE  
Date Received12/17/2014
Decision Date 06/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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