510(k) K223809
- Device
- PrecisionTAVI (v1.1)
- Applicant
- Dasi Simulations
- 510(k) number
- K223809
- Product code
- QQI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-30
- Date received
- 2022-12-20
- Regulation
- 870.1405
- Classification name
- Interventional Cardiovascular Implant Simulation Software Device
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ana Minyayev
- Address
- 5115 Parkcenter Ave. Suite 205 Dublin OH US 43017 43017
FDA Registration Numbers#
- 3020703662
- 3030707552