Device Classification Name |
coronary vascular physiologic simulation software
|
De Novo Number |
DEN130045 |
Device Name |
HEARTFLOW FFRCT |
Requester |
heartflow |
1400 seaport blvd |
building b |
redwood city,
CA
94063
|
|
Contact |
dustin michaels |
|
Regulation Number | 870.1415
|
Classification Product Code |
|
Date Received | 11/04/2013 |
Decision Date | 11/26/2014 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|