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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K233976
Device Name VasoGuard (V10, V8, V6, V4, V2)
Applicant
Corvascular Diagnostics, LLC
600 Twelve Oaks Center Dr.
Suite 102
Wayzata,  MN  55391
Applicant Contact Spencer Lien
Correspondent
ProMedic Consulting, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number870.2880
Classification Product Code
JOP  
Date Received12/15/2023
Decision Date 07/19/2024
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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