510(k) K190194 ยท GEH Unit, Cryosurgical, Accessories
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
| Applicant | Pentax Medical, A Division of Pentax of America, Inc., Redwood, Ca CA, US |
| Decision | Substantially Equivalent, May 31, 2019 |
| Received | Feb 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190194
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.