510(k) K050889 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH
| Applicant | Crs Medical Diagnostics, Inc., Pewaukee WI, US |
| Decision | Substantially Equivalent, Aug 26, 2005 |
| Received | Apr 6, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050889
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.