510(k) K970049 ยท ITX Transducer, Ultrasonic, Diagnostic
BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/
| Applicant | Cardiovascular Imaging Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 20, 1997 |
| Received | Jan 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970049
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.