Clearance Summary
Thoratec CentriMag Return (Arterial) Cannula Kit received FDA 510(k) clearance under submission number K152161, sponsored by 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 2015-09-18.
- Submission: K152161
- Applicant / Sponsor: Thoratec Corporation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 2015-09-18
Classification & Regulation
This clearance is catalogued under FDA product code DWF and 21 CFR 870.4210, within the Cardiovascular review panel as a Class II device.