510(k) K203540 ยท MJN Catheter, Intravascular Occluding, Temporary
Bridge Occlusion Balloon
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Dec 23, 2020 |
| Received | Dec 3, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203540
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.