DeviceClearance

VitalFlow Set with Balance Biosurface— 510(k) K261335

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.

Summary

Medtronic's VitalFlow Set with Balance Biosurface is filed under QJZ, extracorporeal systems for long-term respiratory or cardiopulmonary failure. The record doesn't list the set's components or say what the Balance Biosurface is.

Class II, 21 CFR 870.4100. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).

Medtronic filed from Minneapolis, Minnesota. The decision came 99 calendar days after FDA received it (April 23 to July 31, 2026).

Clearance details

Applicant
Medtronic, Inc.
Product code
Product code QJZ
Device class
Class 2
Regulation
21 CFR 870.4100
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code QJZ

product code QJZ
Death
22
Total
22

Source: openFDA MAUDE database, through . 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.