510(k) K921148 ยท ITX Transducer, Ultrasonic, Diagnostic
CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE
| Applicant | Cardiovascular Imaging Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 16, 1992 |
| Received | Mar 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921148
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.