Clearance Summary
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres received FDA 510(k) clearance under submission number K173871, sponsored by Suzhou Hengrui Callisyn Biomedical Co., 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 2018-09-17.
- Submission: K173871
- Applicant / Sponsor: Suzhou Hengrui Callisyn Biomedical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3300
- Decision date: 2018-09-17
Classification & Regulation
This clearance is catalogued under FDA product code NAJ and 21 CFR 870.3300, within the Cardiovascular review panel as a Class II device.