PrecisionTAVI (v1.1)— 510(k) K223809

Substantially Equivalent

Dasi Simulations

FDA 510(k) clearance K223809 for PrecisionTAVI (v1.1), Substantially Equivalent on 2023-05-30. Applicant: Dasi Simulations.

Clearance details

Applicant: Dasi Simulations
Product code: Code QQI
Advisory panel: Cardiovascular
Date received: 2022-12-20
Decision date: 2023-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, OH, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.