510(k) K191871 ยท DYB Introducer, Catheter
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Aug 7, 2019 |
| Received | Jul 12, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191871
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2024 | Boston Scientific Corporation Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.