Clearance Summary
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit received FDA 510(k) clearance under submission number K200306, sponsored by Abbott (Formerly Thoratec Corporation). The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-03-06.
- Submission: K200306
- Applicant / Sponsor: Abbott (Formerly Thoratec Corporation)
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4380
- Decision date: 2020-03-06
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.