PrecisionTAVI (v1.1)
K-Number: K223809 · 2023-05-30
ApplicantDasi Simulations
Decision Date2023-05-30
Product CodeQQI
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PrecisionTAVI (v1.1) is a medical device manufactured by Dasi Simulations. It received FDA 510(k) clearance on 2023-05-30 under approval number K223809. The device is classified under product code QQI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PrecisionTAVI (v1.1)?
PrecisionTAVI (v1.1) is a medical device that received FDA 510(k) clearance on 2023-05-30. It is manufactured by Dasi Simulations. The 510(k) number is K223809.
When was PrecisionTAVI (v1.1) approved by the FDA?
PrecisionTAVI (v1.1) received FDA 510(k) clearance on 2023-05-30, under approval number K223809.
What company makes PrecisionTAVI (v1.1)?
PrecisionTAVI (v1.1) is manufactured by Dasi Simulations.
What is the FDA product code for PrecisionTAVI (v1.1)?
The FDA product code for PrecisionTAVI (v1.1) is QQI.
Other Devices by Dasi Simulations
Related Devices (Code: QQI)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.