VitalFlow Set with Balance Biosurface— 510(k) K261335

Name: FDA 510(k) clearance K261335
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K261335 for VitalFlow Set with Balance Biosurface, Substantially Equivalent on 2026-07-31. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code QJZ
Device class: Class 2
Regulation: 21 CFR 870.4100
Advisory panel: Cardiovascular
Date received: 2026-04-23
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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.