510(k) K233170 ยท GXH Device, Surgical, Cryogenic
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
| Applicant | AtriCure, Inc., Mason OH, US |
| Decision | Substantially Equivalent, Oct 26, 2023 |
| Received | Sep 27, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233170
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.