510(k) K102527 ยท KOD Catheter, Urological
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Nov 5, 2010 |
| Received | Sep 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102527
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.