510(k) DEN230069
- Device
- Mi-CHORD System
- Applicant
- Lsi Solutions, Inc.
- 510(k) number
- DEN230069
- Product code
- SBK
- Decision
- Unknown (DENG)
- Decision date
- 2024-06-11
- Date received
- 2023-09-29
- Regulation
- 870.3490
- Classification name
- Artificial Chordae Tendineae Surgical Replacement System
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Christopher B. Miller
- Address
- 7796 Victor-Mendon Rd. Victor NY US 14564 14564
FDA Registration Numbers#
- 1320468
Source Documents#
510(k) summary PDF not indicated by FDA