Clearance Summary
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating received FDA 510(k) clearance under submission number K153140, sponsored by Terumo Cardiovascular Systems Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-12-02.
- Submission: K153140
- Applicant / Sponsor: Terumo Cardiovascular Systems Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4350
- Decision date: 2015-12-02
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.