510(k) K180137 ยท GEH Unit, Cryosurgical, Accessories
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
| Applicant | AtriCure, Inc., Mason OH, US |
| Decision | Substantially Equivalent, Feb 15, 2018 |
| Received | Jan 17, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180137
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.