510(k) K211830
K211830 is an FDA 510(k) premarket notification submitted by Cardiacassist, Inc. for the device "LifeSPARC System". The FDA issued a decision of Substantially Equivalent on November 15, 2022. The device falls under product code QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use), a Class II device regulated under 21 CFR 870.4100. Cardiacassist, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2022
- Date Received
- June 14, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
- Device Class
- Class II
- Regulation Number
- 870.4100
- Review Panel
- CV
- Submission Type
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.