DeviceClearance

Product code SGO— Cardiovascular

TELLTALE Electrosurgical Guidewire System

Classification name
Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Device class
Class 2
Regulation
21 CFR 870.1254
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code SGO under 21 CFR 870.1254, via openFDA

Market context for product code SGO

FDA has cleared 1 device under product code SGO, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGO

Recent clearances under product code SGO

Data sourced from openFDA. This site is unofficial and independent of the FDA.