Clearance Summary
COSEAL received FDA 510(k) clearance under submission number K131411, sponsored by Jilin Coronado Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-09-26.
- Submission: K131411
- Applicant / Sponsor: Jilin Coronado Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2013-09-26
Classification & Regulation
This clearance is catalogued under FDA product code DXC and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.