510(k) K970823 ยท DQY Catheter, Percutaneous
SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER
| Applicant | Scimed Life Systems, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Jun 3, 1997 |
| Received | Mar 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970823
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2009 | Boston Scientific Corporation Boston Scientific Wiseguide, Guide Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 22650 MEX.
Boston Scien Terminated |
DQO | None listed |
| Jun 18, 2009 | Boston Scientific Corporation Boston Scientific Wiseguide Guide Catheter, Sterilized.
Wiseguide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical inst Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.