DeviceClearance

Product code SBK— Cardiovascular

Mi-CHORD System

Classification name
Artificial Chordae Tendineae Surgical Replacement System
Device class
Class 2
Regulation
21 CFR 870.3490
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SBK under 21 CFR 870.3490, via openFDA

Market context for product code SBK

FDA has cleared 1 device under product code SBK, all in 2024, 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 SBK

Recent clearances under product code SBK

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