510(k) K973645 ยท KRA Catheter, Continuous Flush
RENEGADE FIBER BRAIDED MICROCATHETER
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Nov 19, 1997 |
| Received | Sep 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973645
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2010 | Boston Scientific Corporation Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only;
Model Numbers: 18257, 18259; Product is distributed by
Boston Scientific Corporation, Natick, MA;
Product is manufa Terminated |
KRA | None listed |
| Nov 14, 2006 | Boston Scientific Target Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570 Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.