LifeSPARC System
FDA 510(k) K211830 · Cardiacassist, Inc.
510(k) numberK211830
Submission
- Device name
- LifeSPARC System
- Applicant
- Cardiacassist, Inc.
Pittsburg, PA, US - Received
- June 14, 2021
- Decision date
- November 15, 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 |
| K222038 | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support SystemQNR · Traditional | Abbott (Formerly Thoratec Corporation) | 12/08/2022SE |
| K202751 | TandemHeart Pump and Escort ControllerQNR · Traditional | Cardiacassist, Inc. | 03/26/2021SE |
More from Cardiacassist, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233736 | LifeSPARC SystemQNR · Traditional | 01/19/2024SE |
| K232480 | ProtekDuo Veno-Venous Cannula SetsPZS · Traditional | 10/06/2023SE |
| K232132 | LifeSPARC SystemKFM · Special | 08/03/2023SE |
| K202751 | TandemHeart Pump and Escort ControllerQNR · Traditional | 03/26/2021SE |
| K183623 | LifeSPARC Pump, LifeSPARC ControllerKFM · Traditional | 07/09/2019SE |
| K181150 | ProtekDuo Mini Veno-Venous Cannula SetDWF · Special | 05/25/2018SE |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetDRE · Traditional | 01/06/2017SE |
| K162214 | Protek Solo 24 Fr Venous Cannula SetDWF · Traditional | 11/30/2016SE |
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula SetDWF · Special | 03/04/2016SE |
| K153295 | TandemLung OxygenatorDTZ · Traditional | 02/26/2016SE |
Questions and answers
When was LifeSPARC System cleared by the FDA?
LifeSPARC System (K211830) received a 510(k) decision of Substantially Equivalent on November 15, 2022, 519 days after the submission was received.
What is the product code of K211830?
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.