SBK

Artificial Chordae Tendineae Surgical Replacement System

Product code

SBK

Device name

Artificial Chordae Tendineae Surgical Replacement System

Device class

Class 2

21 CFR

21 CFR 870.3490

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Implant

Flag

Life-sustaining / life-supporting

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

An artificial chordae tendineae surgical replacement system is a standalone, prescription device consisting of nonabsorbable suture-based implant and suture placement device(s) that is used to replace mitral or tricuspid chordae tendineae in patients with atrioventricular valve insufficiency. The device includes clips or fasteners to secure suture that are not embedded in the cardiac tissue. The system is used via surgical approach under direct visualization and not via transcatheter or percutaneous access.

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: 2024-06-11.