K240880

Substantially Equivalent

VitalFlow Set with Balance Biosurface

Applicant: Medtronic, Inc.
Product 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

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.