510(k) K050808 ยท LYK Angioscope
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
| Applicant | Cardio-Optics, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Jul 28, 2005 |
| Received | Mar 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050808
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.