510(k) K223809
K223809 is an FDA 510(k) premarket notification submitted by Dasi Simulations for the device "PrecisionTAVI (v1.1)". The FDA issued a decision of Substantially Equivalent on May 30, 2023. The device falls under product code QQI (Interventional Cardiovascular Implant Simulation Software Device), a Class II device regulated under 21 CFR 870.1405. Dasi Simulations has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2023
- Date Received
- Dec 20, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interventional Cardiovascular Implant Simulation Software Device
- Device Class
- Class II
- Regulation Number
- 870.1405
- Review Panel
- CV
- Submission Type
An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patients cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.