510(k) K011965 ยท KOD Catheter, Urological
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Jul 13, 2001 |
| Received | Jun 25, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011965
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2012 | Boston Scientific Corporation Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760 Terminated |
KOD | None listed |
| Jan 21, 2010 | Boston Scientific Corporation Imager" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7 Terminated |
KOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.