510(k) K201183 ยท GEH Unit, Cryosurgical, Accessories
Vortex Radial Spray Catheter
| Applicant | CSA Medical, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Dec 7, 2020 |
| Received | May 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201183
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.