Device Classification Name |
balloon aortic valvuloplasty
|
De Novo Number |
DEN080015 |
510(K) Number |
K082776
|
Device Name |
NUCLEUS-X PTV CATHETER |
Requester |
numed, inc. |
2880 main st. |
hopkinton,
NY
12965
|
|
Contact |
nichelle laflesh |
|
Regulation Number | 870.1255
|
Classification Product Code |
|
Date Received | 12/24/2008 |
Decision Date | 06/11/2012 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|