Clearance Summary
Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir received FDA 510(k) clearance under submission number K153213, sponsored by Terumo Cardiovascular Systems 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 2015-12-03.
- Submission: K153213
- Applicant / Sponsor: Terumo Cardiovascular Systems Corporation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4350
- Decision date: 2015-12-03
Classification & Regulation
This clearance is catalogued under FDA product code DTZ and 21 CFR 870.4350, within the Cardiovascular review panel as a Class II device.