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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
Applicant
Cardiogard Medical, Ltd.
6 Yoni Netanyahu St.
Or Yehuda,  IL 6037604
Applicant Contact Orit Ronan
Correspondent
Heyer Regulatory Solutions, LLC
125 Cherry Ln.
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number870.4210
Classification Product Code
DWF  
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
Predetermined Change
Control Plan Authorized		 No
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