Clearance Summary
Advanced Perfusion System 1 received FDA 510(k) clearance under submission number K163531, sponsored by Terumo Cardiovascular Systems 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 2017-06-07.
- Submission: K163531
- Applicant / Sponsor: Terumo Cardiovascular Systems Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4220
- Decision date: 2017-06-07
Classification & Regulation
This clearance is catalogued under FDA product code DTQ and 21 CFR 870.4220, within the Cardiovascular review panel as a Class II device.