510(k) K252592
K252592 is an FDA 510(k) premarket notification submitted by Telltale, LLC for the device "TELLTALE Electrosurgical Guidewire System". The FDA issued a decision of Substantially Equivalent on Nov 13, 2025. The device falls under product code SGO (Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures), a Class II device regulated under 21 CFR 870.1254.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 13, 2025
- Date Received
- Aug 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