SGO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1254
- Medical specialty
- Cardiovascular
- FDA definition
- The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure
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| Record | Firm | Date |
|---|---|---|
| TELLTALE Electrosurgical Guidewire System (K252592) | Telltale, LLC | 2025-11-13 |
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