SGO

Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Product code

SGO

Device name

Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Device class

Class 2

21 CFR

21 CFR 870.1254

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-11-13.

1 summaries are archived here for direct download.