510(k) K210627 ยท DYB Introducer, Catheter
Breezeway II
| Applicant | Oscor, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Jun 3, 2021 |
| Received | Mar 2, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210627
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.