PrecisionTAVI (v1.1)— 510(k) K223809
Substantially EquivalentDasi Simulations
FDA 510(k) clearance K223809 for PrecisionTAVI (v1.1), Substantially Equivalent on 2023-05-30. Applicant: Dasi Simulations. Device class: 2.
Clearance details
- Applicant
- Dasi Simulations
- Product code
- Code QQI
- Device class
- Class 2
- Regulation
- 21 CFR 870.1405
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin, OH, US
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