510(k) K170385 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
CORE M2 Vascular System
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Apr 6, 2017 |
| Received | Feb 8, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170385
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.