DUO Microcatheter— 510(k) K250960

Substantially Equivalent

Rev Neuro, LLC

FDA 510(k) clearance K250960 for DUO Microcatheter, Substantially Equivalent on 2025-09-08. Applicant: Rev Neuro, LLC.

Clearance details

Applicant: Rev Neuro, LLC
Product code: Code QJP
Advisory panel: Cardiovascular
Date received: 2025-03-31
Decision date: 2025-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasonton, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QJP

product code QJP

Death: 43
Injury: 233
Malfunction: 1,010
Total: 1,286

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.