SGO — Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K252592telltaleTELLTALE Electrosurgical Guidewire SystemNovember 13, 2025