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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
510(k) Number K252592
Device Name TELLTALE Electrosurgical Guidewire System
Applicant
Telltale, LLC
4 Dundee Park Dr.
Suite 101
Andover,  MA  01810
Applicant Contact Koosha Rafiee
Correspondent
Telltale, LLC
4 Dundee Park Dr.
Suite 101
Andover,  MA  01810
Correspondent Contact Koosha Rafiee
Classification Product Code
SGO  
Date Received08/15/2025
Decision Date 11/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05666713
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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