Clearance Summary
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II received FDA 510(k) clearance under submission number K073559, sponsored by Edwards Lifesciences Research Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-01-31.
- Submission: K073559
- Applicant / Sponsor: Edwards Lifesciences Research Medical
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1300
- Decision date: 2008-01-31
Classification & Regulation
This clearance is catalogued under FDA product code DQR and 21 CFR 870.1300, within the Cardiovascular review panel as a Class II device.