510(k) K934541 ยท DQO Catheter, Intravascular, Diagnostic
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION
| Applicant | Scimed Life Systems, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, May 12, 1994 |
| Received | Sep 16, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934541
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2009 | Boston Scientific Corporation Boston Scientific Expo, Angiographic Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 22650 MEX.
Boston Sci Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.