510(k) K190813 ยท PON Catheter, Balloon, Dilation Of Cervical Canal
CrossBay Cervical Dilator Catheter System
| Applicant | Crossbay Medical, San Diego CA, US |
| Decision | Substantially Equivalent, Aug 23, 2019 |
| Received | Mar 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190813
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.