Clearance Summary
R2P Metacross RX received FDA 510(k) clearance under submission number K163479, sponsored by KANEKA 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 2017-01-11.
- Submission: K163479
- Applicant / Sponsor: KANEKA Corporation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2017-01-11
Classification & Regulation
This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.