510(k) K160583 ยท OBJ Catheter, Ultrasound, Intravascular
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 26, 2016 |
| Received | Mar 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160583
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2017 | Volcano Corporation Refinity Rotational Intravascular Ultrasound (IVUS) Catheter;
Product number: 400-0200.289; Catalog number 89800.
Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or Terminated |
OBJ | None listed |
| Apr 10, 2017 | Volcano Corporation Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter;
Product number: 400-0200.273; Catalog number 89900.
Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (R Terminated |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.