K252592 is an FDA 510(k) clearance for the TELLTALE Electrosurgical Guidewire System. This device is classified as a Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures (Class II - Special Controls, product code SGO).
Submitted by Telltale, LLC (Andover, US). The FDA issued a Cleared decision on November 13, 2025, 90 days after receiving the submission on August 15, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1254. The Device Is Intended For Electrosurgically Splitting Valve Leaflets To Facilitate A Planned Valvular Procedure.
| 510(k) Number | K252592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2025 |
| Decision Date | November 13, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | SGO - Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1254 |
| Definition | The Device Is Intended For Electrosurgically Splitting Valve Leaflets To Facilitate A Planned Valvular Procedure |