SGOClass II
Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
21 CFR 870.1254 / Cardiovascular
SGO is the FDA product code for Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures, a class II device type, regulated under 21 CFR 870.1254. FDA's definition for this code reads: "The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SGO
- Device name
- Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- FDA definition
- The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure
- Regulation
- 21 CFR 870.1254
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SGO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code SGO| Applicant | Clearances |
|---|---|
| Telltale, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code SGO.
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