510(k) K982840 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING
| Applicant | Boston Scientific Corp, San Jose CA, US |
| Decision | Substantially Equivalent, Nov 9, 1998 |
| Received | Aug 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982840
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.