DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Medtronic, Inc.
Product code
Code QNR
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 QNR

product code QNR
Death
11
Total
11

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 →

Recalls naming K250199

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250199.

Data sourced from openFDA. This site is unofficial and independent of the FDA.