SBK — Artificial Chordae Tendineae Surgical Replacement System Class II
FDA product code SBK covers "Artificial Chordae Tendineae Surgical Replacement System", a Class II medical device regulated under 21 CFR 870.3490. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SBK
- Device Class
- Class II
- Regulation Number
- 870.3490
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230069 | lsi solutions | Mi-CHORD System | June 11, 2024 |