510(k) K173860 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Apr 11, 2018 |
| Received | Dec 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173860
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.