VitalFlowTM Centrifugal Pump— 510(k) K223898
Substantially EquivalentMichigan 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.).
Clearance details
- Applicant
- Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
- Product code
- Code QNR
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dexter, MI, US
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.