Clearance Summary
Microcatheter and guide-wire system received FDA 510(k) clearance under submission number K171665, sponsored by Suzhou Hengrui Disheng Medical 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 2018-01-11.
- Submission: K171665
- Applicant / Sponsor: Suzhou Hengrui Disheng Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1210
- Decision date: 2018-01-11
Classification & Regulation
This clearance is catalogued under FDA product code KRA and 21 CFR 870.1210, within the Cardiovascular review panel as a Class II device.