510(k) K212814 ยท GEH Unit, Cryosurgical, Accessories
C2 CryoBalloon Ablation System
| Applicant | Pentax of America, Inc., Redwood, Ca CA, US |
| Decision | Substantially Equivalent, Nov 29, 2021 |
| Received | Sep 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212814
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.