VitalFlow Console— 510(k) K250199

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K250199 for VitalFlow Console, Substantially Equivalent on 2025-05-20. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code QNR
Advisory panel: Cardiovascular
Date received: 2025-01-23
Decision date: 2025-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QNR

product code QNR

Death: 11
Total: 11

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.