SGO — Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures Class II
FDA product code SGO covers "Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures", a Class II medical device regulated under 21 CFR 870.1254. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SGO
- Device Class
- Class II
- Regulation Number
- 870.1254
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252592 | Telltale | TELLTALE Electrosurgical Guidewire System | Nov 13, 2025 |