510(k) K200697 ยท GXH Device, Surgical, Cryogenic
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
| Applicant | AtriCure, Inc., Mason OH, US |
| Decision | Substantially Equivalent, Dec 23, 2020 |
| Received | Mar 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200697
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.