Clearance Summary
One Way Soft Valve received FDA 510(k) clearance under submission number K142500, 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 2015-01-29.
- Submission: K142500
- Applicant / Sponsor: Terumo Cardiovascular Systems Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4400
- Decision date: 2015-01-29
Classification & Regulation
This clearance is catalogued under FDA product code MJJ and 21 CFR 870.4400, within the Cardiovascular review panel as a Class II device.