510(k) K911414 ยท ITX Transducer, Ultrasonic, Diagnostic
CVIS INSIGHT IMAGING CATHETERS
| Applicant | Cardiovascular Imaging Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 11, 1991 |
| Received | Apr 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911414
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.