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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K182302
Device Name CardioGard Emboli Protection Cannula
CardioGard Medical Ltd
6 Yoni Netanyahu Street
or-yehuda,  IL 6037604
Applicant Contact orit ronan
Heyer Regulatory Solutions, LLC
125 Cherry Lane
amherst,  MA  01002
Correspondent Contact sheila hemeon-heyer
Regulation Number870.4210
Classification Product Code
Date Received08/24/2018
Decision Date 05/17/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No