510(k) K974541 ยท FAD Stent, Ureteral
MODIFIED URETERAL INDWELLING CATHETER/STENT
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Feb 9, 1998 |
| Received | Dec 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974541
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2020 | Boston Scientific Corporation Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570 Open, Classified |
FAD | None listed |
| Nov 16, 2020 | Boston Scientific Corporation Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190 Open, Classified |
FAD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.