Artificial Chordae Tendineae Surgical Replacement System
SBK · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3490
Classification
FDA Product Code
SBK
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.3490
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
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.