510(k) DEN230069
DEN230069 is an FDA 510(k) premarket notification submitted by Lsi Solutions, Inc. for the device "Mi-CHORD System". The FDA issued a decision of De Novo Granted on June 11, 2024. The device falls under product code SBK (Artificial Chordae Tendineae Surgical Replacement System), a Class II device regulated under 21 CFR 870.3490. Lsi Solutions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 11, 2024
- Date Received
- September 29, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Artificial Chordae Tendineae Surgical Replacement System
- Device Class
- Class II
- Regulation Number
- 870.3490
- Review Panel
- CV
- Submission Type
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.