510(k) K000177 ยท KRA Catheter, Continuous Flush
RENEGADE HI-FLO MICROCATHETER
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Apr 7, 2000 |
| Received | Jan 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2010 | Boston Scientific Corporation Boston Scientific brand Neuro Renegade Hi-Flo Microcatheter, 150cm/20cm; Rx Only;
Model Numbers: 182880US, 182890US, 182900US, 182910US; Product is distributed by
Boston Scientific Corporation, Natic Terminated |
KRA | None listed |
| 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 |
| Sep 24, 2009 | Boston Scientific Corporation Boston Scientific Renegade" Hi Flo Microcatheter (neurovascular use) REF 18-288OUS, Sterilized using ethylene oxide, Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place, Na Terminated |
KRA | None listed |
| Oct 31, 2007 | Boston Scientific Corporation Boston Scientific-Renegade Hi-Flo Microcatheter Kit,
UPN Material Number: MOO1183030,Catalog Number: 18-303 Terminated |
KRA | None listed |
| Nov 1, 2006 | Boston Scientific Corporation Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990 Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.