510(k) K152329 ยท GEH Unit, Cryosurgical, Accessories
Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System
| Applicant | C2 Therapeutics, Inc., Redwood, Ca CA, US |
| Decision | Substantially Equivalent, Apr 13, 2016 |
| Received | Aug 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152329
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2017 | C2 Therapeutics, Inc. C2 CryoBalloon Ablation System - Controller Cap.
C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device
The affected product is the Controller Cap component only, which is provided to Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.