Data / Medical devices / United States / Dasisimulations, LLC
Dasisimulations, LLC: FDA-registered device maker in Dublin, OH, United States, 1 510(k) clearance
Dasisimulations, LLC is registered with the FDA (registration 3030707552) in Dublin, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3030707552
- Address
- 6500 Emerald Pkwy Suite 200, Dublin, OH, United States, 43016
- Owner or operator
- Dasisimulations, LLC (10090418)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 26, 2024
- Registered through
- 2026
- Brand names listed
- PrecisionTAVI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interventional Cardiovascular Implant Simulation Software Device | QQI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2023 | K223809 | PrecisionTAVI (v1.1) | QQI | Substantially Equivalent | Dasi Simulations | accessdata.fda.gov |
Updated May 30, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.