Data / Medical devices / United States / Anteris Technologies Corporation
Anteris Technologies Corporation: FDA-registered device maker in Eagan, MN, United States, 1 510(k) clearance
Anteris Technologies Corporation is registered with the FDA (registration 3012664855) in Eagan, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 3, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012664855
- Address
- 860 Blue Gentian Rd Ste 340, Eagan, MN, United States, 55121
- Owner or operator
- Anteris Technology Corporation (10046278)
- Roles
- Specification developer
- First device listed
- June 9, 2020
- Registered through
- 2026
- Brand names listed
- ADAPT Tissue
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intracardiac Patch Or Pledget, Biologically Derived | PSQ | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 3, 2020 | K200566 | ADAPT Tissue | PSQ | Substantially Equivalent | Admedus Regen Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 3, 2020. 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.