Clearance Summary
Distal Access Catheter received FDA 510(k) clearance under submission number K213065, sponsored by Guangzhou Easycess 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 2022-05-31.
- Submission: K213065
- Applicant / Sponsor: Guangzhou Easycess Medical Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2022-05-31
Classification & Regulation
This clearance is catalogued under FDA product code QJP and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.