510(k) K190184 ยท DYB Introducer, Catheter
iSLEEVE Introducer Set
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Mar 7, 2019 |
| Received | Feb 1, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190184
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.