Clearance Summary
CentriMag Acute Circulatory Support System received FDA 510(k) clearance under submission number K191557, sponsored by Thoratec Corporation (Now Part of Abbott). The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-07-10.
- Submission: K191557
- Applicant / Sponsor: Thoratec Corporation (Now Part of Abbott)
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4380
- Decision date: 2019-07-10
Classification & Regulation
This clearance is catalogued under FDA product code DWA and 21 CFR 870.4380, within the Cardiovascular review panel as a Class II device.