SBK

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Artificial Chordae Tendineae Surgical Replacement System

Device class

Class II (moderate risk)

Regulation

21 CFR 870.3490

Medical specialty

Cardiovascular

Flags

Implant · Life-sustaining

FDA 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.

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