510(k) K970854 ยท DQO Catheter, Intravascular, Diagnostic
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Sep 30, 1997 |
| Received | Mar 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970854
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2023 | Cordis US Corp Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter Open, Classified |
DQO | None listed |
| Dec 16, 2022 | Cordis US Corp Cordis Angiographic Catheter Extensions.
Used to transport fluid from the power injector to the catheter for injection into the patient. Open, Classified |
DQO | None listed |
| Jul 13, 2006 | Cordis Corporation Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is:
534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T, 534628T, 534629T, Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.