510(k) K023681 ยท DQO Catheter, Intravascular, Diagnostic
RENEGADE STC 18 MICROCATHETER
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Nov 26, 2002 |
| Received | Nov 1, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023681
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2009 | Boston Scientific Corporation Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylene Oxide. Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm R Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.