510(k) K897153 ยท LYK Angioscope
CVIS INSIGHT IMAGING CATHETER
| Applicant | Cardiovascular Imaging Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 26, 1990 |
| Received | Dec 26, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897153
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.