510(k) K202584 ยท DYB Introducer, Catheter
iSleeve Introducer Set
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 6, 2020 |
| Received | Sep 8, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202584
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.