510(k) K140058 ยท GEH Unit, Cryosurgical, Accessories
ATRICURE CRYO MODULE SYSTEM
| Applicant | AtriCure, Inc., West Chester OH, US |
| Decision | Substantially Equivalent, Jan 24, 2014 |
| Received | Jan 10, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140058
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | AtriCure, Inc. Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 Open, Classified |
GEH | None listed |
| Jan 31, 2024 | AtriCure, Inc. Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 Open, Classified |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.