FDA Product Code SGO: Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
The Device Is Intended For Electrosurgically Splitting Valve Leaflets To Facilitate A Planned Valvular Procedure
Leading manufacturers include Telltale, LLC.
1
Total
1
Cleared
90d
Avg days
2025
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures Devices (Product Code SGO)
1 devices
About Product Code SGO - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SGO since 2025, with 1 receiving FDA clearance (average review time: 90 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SGO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →