REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip— 510(k) K160583

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K160583 for REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip, Substantially Equivalent on 2016-10-26. Applicant: Volcano Corporation.

Clearance details

Applicant: Volcano Corporation
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2016-03-01
Decision date: 2016-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.