510(k) K160994 ยท GEH Unit, Cryosurgical, Accessories
C2 CryoBalloon Focal Pear Catheter
| Applicant | C2 Therapeutics, Inc., Redwood, Ca CA, US |
| Decision | Substantially Equivalent, May 19, 2016 |
| Received | Apr 8, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160994
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.