510(k) K934581 ยท DQO Catheter, Intravascular, Diagnostic
SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS
| Applicant | Scimed Life Systems, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 31, 1994 |
| Received | Sep 23, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934581
| 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.