QNR — Blood Pump For Ecmo, Long-Term (> 6 Hours) Use Class II
Classification Details
- Product Code
- QNR
- Device Class
- Class II
- Regulation Number
- 870.4100
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250199 | medtronic | VitalFlow Console | May 20, 2025 |
| K234118 | abbott medical | CentriMag Acute Circulatory Support System | January 26, 2024 |
| K233736 | cardiacassist | LifeSPARC System | January 19, 2024 |
| K223898 | michigan critical care consultants, inc. (d.b.a mc3 inc.) | VitalFlowTM Centrifugal Pump | August 25, 2023 |
| K230364 | michigan critical care consultants, inc. (d.b.a mc3 inc.) | VitalFlow Console | August 25, 2023 |
| K222038 | abbott (formerly thoratec corporation) | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System | December 8, 2022 |
| K211830 | cardiacassist | LifeSPARC System | November 15, 2022 |
| K202751 | cardiacassist | TandemHeart Pump and Escort Controller | March 26, 2021 |