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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K231148
Device Name ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
Applicant
VVT Medical Ltd.
6 Hasadna St.
Kfar Saba,  IL 4442405
Applicant Contact Liron Tayeb
Correspondent
Hogan Lovells US LLP
555 13th Street, NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number870.1210
Classification Product Code
KRA  
Subsequent Product Code
FMF  
Date Received04/21/2023
Decision Date 06/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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