Clearance Summary
CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System received FDA 510(k) clearance under submission number K222038, sponsored by Abbott (Formerly Thoratec Corporation). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-12-08.
- Submission: K222038
- Applicant / Sponsor: Abbott (Formerly Thoratec Corporation)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4100
- Decision date: 2022-12-08
Classification & Regulation
This clearance is catalogued under FDA product code QNR and 21 CFR 870.4100, within the Cardiovascular review panel as a Class II device.