510(k) K252592

Device

TELLTALE Electrosurgical Guidewire System

Applicant

Telltale, LLC

510(k) number

K252592

Product code

SGO

Decision

Substantially Equivalent (SESE)

Decision date

2025-11-13

Date received

2025-08-15

Regulation

870.1254

Classification name

Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N