RIO ASPIRATION CATHETER— 510(k) K051880

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K051880 for RIO ASPIRATION CATHETER, Substantially Equivalent on 2006-01-04. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2005-07-11
Decision date: 2006-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.