CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System
FDA 510(k) K222038 · Abbott (Formerly Thoratec Corporation)
Submission
- Device name
- CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System
- Applicant
- Abbott (Formerly Thoratec Corporation)
Pleasanton, CA, US - Received
- July 11, 2022
- Decision date
- December 8, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNR – Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4100
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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…
Other 510(k)s with product code QNR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250199 | VitalFlow ConsoleQNR · Traditional | Medtronic, Inc. | 05/20/2025SE |
| K234118 | CentriMag Acute Circulatory Support SystemQNR · Special | Abbott Medical | 01/26/2024SE |
| K233736 | LifeSPARC SystemQNR · Traditional | Cardiacassist, Inc. | 01/19/2024SE |
| K230364 | VitalFlow ConsoleQNR · Traditional | Michigan Critical Care Consultants, Inc. (D.B.A… | 08/25/2023SE |
| K223898 | VitalFlowTM Centrifugal PumpQNR · Traditional | Michigan Critical Care Consultants, Inc. (D.B.A… | 08/25/2023SE |
| K211830 | LifeSPARC SystemQNR · Traditional | Cardiacassist, Inc. | 11/15/2022SE |
| K202751 | TandemHeart Pump and Escort ControllerQNR · Traditional | Cardiacassist, Inc. | 03/26/2021SE |
More from Cardiacassist, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…DWA · Special | 03/06/2020SE |
Questions and answers
When was CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System cleared by the FDA?
CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System (K222038) received a 510(k) decision of Substantially Equivalent on December 8, 2022, 150 days after the submission was received.
What is the product code of K222038?
The FDA product code is QNR – Blood Pump For Ecmo, Long-Term (> 6 Hours) Use, a Class II (moderate risk) device regulated under 21 CFR 870.4100.