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510(k) K252592

TELLTALE Electrosurgical Guidewire System by Telltale, LLC — Product Code SGO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 13, 2025
Date Received: August 15, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Device Class: Class II
Regulation Number: 870.1254
Review Panel: CV
Submission Type

The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure