# K252592: TELLTALE Electrosurgical Guidewire System

- Pathway: 510(k) (Traditional)
- Applicant: Telltale, LLC
- Decided: Nov 13, 2025 after 90 days
- Product code: SGO (Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures)
- Device class: 2
- Regulation: 21 CFR 870.1254
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN240017 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN240017: ShortCut, Pi-Cardia, Ltd. (2024) Summary page 5.

## Indications for use
The TELLTALE Electrosurgical Guidewire System is indicated for transcatheter electrosurgical traversal and laceration of native and bioprosthetic tissue in patients at risk of coronary obstruction during TAVR.

Source page: https://510kreport.com/device/K252592
Methodology: https://510kreport.com/methodology