Clearance Summary
Radifocus Optitorque Angiographic Catheter received FDA 510(k) clearance under submission number K150232, sponsored by Ashitaka Factory of Terumo Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-10-19.
- Submission: K150232
- Applicant / Sponsor: Ashitaka Factory of Terumo Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2015-10-19
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.