Artificial Chordae Tendineae Surgical Replacement System
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.3490
Review panel
CV
Implant
Y
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.