Data / Medical devices / United States / AtriCure - Minneapolis
AtriCure - Minneapolis: FDA-registered device maker in Minnetonka, MN, United States, 2 510(k) clearances
AtriCure - Minneapolis is registered with the FDA (registration 3011788769) in Minnetonka, MN, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 22, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011788769
- Address
- 130 Cheshire Ln Ste 250, Minnetonka, MN, United States, 55305
- Owner or operator
- ATRICURE, INC. (9045049)
- Roles
- Specification developer
- First device listed
- April 3, 2015
- Registered through
- 2026
- Brand names listed
- AtriCure cryoICE cryoFORM cryoablation probe (CRYOF), CRYO3 - AtriCure cryoICE cryo-ablation probe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | 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 |
|---|---|---|---|---|---|---|
| March 22, 2016 | K152337 | cryoFORM cryoICE cryoablation probe | GEH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| October 29, 2014 | K142441 | cryoICE croablation probe | GEH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 22, 2016. 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.