DEN230069 is an FDA 510(k) submission for the Mi-CHORD System. This device is classified as a Artificial Chordae Tendineae Surgical Replacement System (Class II - Special Controls, product code SBK).
Submitted by Lsi Solutions, Inc. (Victor, US). The FDA issued a Not Cleared (DENG) decision on June 11, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3490. 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..
| 510(k) Number | DEN230069 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 29, 2023 |
| Decision Date | June 11, 2024 |
| Days to Decision | 256 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | SBK - Artificial Chordae Tendineae Surgical Replacement System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3490 |
| 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. |