510(k) K140291 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
| Applicant | Volcano Corporation, Billerica MA, US |
| Decision | Substantially Equivalent, Mar 7, 2014 |
| Received | Feb 5, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140291
No recall in the FDA data names this 510(k).
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