510(k) K202543 ยท DQX Wire, Guide, Catheter
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Sep 28, 2020 |
| Received | Sep 2, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202543
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2022 | Volcano Corp Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 Terminated |
DXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.