Device Classification Name |
artificial chordae tendineae surgical replacement system
|
De Novo Number |
DEN230069 |
Device Name |
Mi-CHORD System |
Requester |
lsi solutions, inc. |
7796 victor-mendon road |
victor,
NY
14564
|
|
Contact |
christopher b. miller |
|
Regulation Number | 870.3490
|
Classification Product Code |
|
Date Received | 09/29/2023 |
Decision Date | 06/11/2024 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|