510(k) K904618 ยท DQO Catheter, Intravascular, Diagnostic
CVIS INSIGHT IMAGING CATHETER
| Applicant | Cardiovascular Imaging Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 12, 1991 |
| Received | Oct 11, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904618
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.