510(k) K203719 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
IntraSight Mobile
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Jan 19, 2021 |
| Received | Dec 21, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203719
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2022 | Volcano Corp IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 Open, Classified |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.