510(k) K190626 ยท OWB Interventional Fluoroscopic X-Ray System
SyncVision System
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Apr 12, 2019 |
| Received | Mar 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190626
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2022 | Volcano Corporation SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.