510(k) K152829 ยท OBJ Catheter, Ultrasound, Intravascular
Visions PV.014P RX Digital IVUS Catheter
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Nov 19, 2015 |
| Received | Sep 29, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152829
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2025 | Volcano Corp Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use. Open, Classified |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.