Clearance Summary
COLIGN received FDA 510(k) clearance under submission number K131124, 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 2013-08-28.
- Submission: K131124
- Applicant / Sponsor: Jilin Coronado Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4290
- Decision date: 2013-08-28
Classification & Regulation
This clearance is catalogued under FDA product code DTL and 21 CFR 870.4290, within the Cardiovascular review panel as a Class II device.