Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
The Blood Pump for ECMO Long-Term (greater than 6 hours) Use is a cardiovascular device intended as part of an extracorporeal membrane oxygenation (ECMO) circuit to provide assisted extracorporeal circulation and physiologic gas exchange for patients with acute respiratory failure or acute cardiopulmonary failure where other treatments have failed and continued deterioration is expected or death is imminent. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.4100 in the Cardiovascular specialty. It carries product code QNR, is life-sustaining, and is not an implant.
Research product code QNR in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QNR
- Device Class
- FDA class 2
- Regulation Number
- 870.4100
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250199 | VitalFlow Console | May 20, 2025 | Substantially Equivalent | Medtronic, Inc. |
| K234118 | CentriMag Acute Circulatory Support System | Jan 26, 2024 | Substantially Equivalent | ABBOTT MEDICAL |
| K233736 | LifeSPARC System | Jan 19, 2024 | Substantially Equivalent | Cardiacassist, Inc. |
| K230364 | VitalFlow Console | Aug 25, 2023 | Substantially Equivalent | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) |
| K223898 | VitalFlowTM Centrifugal Pump | Aug 25, 2023 | Substantially Equivalent | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) |
| K222038 | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System | Dec 08, 2022 | Substantially Equivalent | Abbott (Formerly Thoratec Corporation) |
| K211830 | LifeSPARC System | Nov 15, 2022 | Substantially Equivalent | Cardiacassist, Inc. |
| K202751 | TandemHeart Pump and Escort Controller | Mar 26, 2021 | Substantially Equivalent | Cardiacassist, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.