VitalFlow Set with Balance Biosurface— 510(k) K240880

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K240880 for VitalFlow Set with Balance Biosurface, Substantially Equivalent on 2024-09-12. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code QJZ
Advisory panel: Cardiovascular
Date received: 2024-04-01
Decision date: 2024-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QJZ

product code QJZ

Death: 22
Total: 22

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.