De Novo DEN130045
- Device
- HEARTFLOW FFRCT
- Contact
- dustin michaels
- De Novo number
- DEN130045
- Product code
- PJA
- Regulation
- 870.1415
- Classification name
- coronary vascular physiologic simulation software
- Decision
- granted (DENG)
- Decision date
- 2014-11-26
- Date received
- 2013-11-04
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- PJA
- Device name
- Coronary Vascular Physiologic Simulation Software
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.1415
- Implant
- N
- Life sustain/support
- N