510(k) K150186 ยท DYB Introducer, Catheter
Chariot Guiding Sheath
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jun 5, 2015 |
| Received | Jan 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150186
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2015 | Boston Scientific Corporation Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide:
Product Description Material Number (UPN)
Guiding Sheath 5F, 45 cm, ST, CC H74939277545110
Guiding Sheath 5F, 45 cm, Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.