510(k) K153541 · GEH Unit, Cryosurgical, Accessories
Coldplay CryoBalloon® Ablation System
| Applicant | C2 Therapeutics, Inc., Redwood, Ca CA, US |
| Decision | Substantially Equivalent, Jan 7, 2016 |
| Received | Dec 10, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153541
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.