VitalFlowTM Centrifugal Pump— 510(k) K223898

Name: FDA 510(k) clearance K223898
Creator: U.S. Food and Drug Administration
Published: 2023-08-25

Substantially Equivalent

Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)

FDA 510(k) clearance K223898 for VitalFlowTM Centrifugal Pump, Substantially Equivalent on 2023-08-25. Applicant: Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). Device class: 2.

Clearance details

Applicant: Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
Product code: Code QNR
Device class: Class 2
Regulation: 21 CFR 870.4100
Advisory panel: Cardiovascular
Date received: 2022-12-28
Decision date: 2023-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dexter, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QNR

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K250199 — VitalFlow Console2025-05-20
K234118 — CentriMag Acute Circulatory Support System2024-01-26
K233736 — LifeSPARC System2024-01-19
K230364 — VitalFlow Console2023-08-25
K222038 — CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System2022-12-08

Adverse events under product code QNR

product code QNR

Death: 11
Total: 11

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.