# DEN230069: Mi-CHORD System

- Pathway: De Novo (Direct)
- Applicant: Lsi Solutions, Inc.
- Decided: Jun 11, 2024 after 256 days
- Product code: SBK (Artificial Chordae Tendineae Surgical Replacement System)
- Device class: 2
- Regulation: 21 CFR 870.3490
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Mi-CHORD System is indicated for the replacement of adult mitral chordae tendineae with the patient on cardiopulmonary bypass, with the heart either arrested or fibrillating, and the surgical field under direct visualization. Direct visualization, in this context, requires that the surgeon is able to see the heart and target tissues in a bloodless field, with or without assistance from an operating telescope or videoscopy.

Source page: https://510kreport.com/device/DEN230069
Methodology: https://510kreport.com/methodology