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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K243928
Device Name ViaOne Epicardial Access System
Applicant
CardioVia Ltd.
Wadi El Haj, 13, P.O. Box 1252
Nazareth,  IL 17111
Applicant Contact Orly Maor
Correspondent
CardioVia Ltd.
Wadi El Haj, 13, P.O. Box 1252
Nazareth,  IL 17111
Correspondent Contact Orly Maor
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/20/2024
Decision Date 03/20/2025
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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