Clearance Summary
Distal Access Catheter received FDA 510(k) clearance under submission number K233205, sponsored by Shanghai Heartcare Medical Technology 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 2023-12-22.
- Submission: K233205
- Applicant / Sponsor: Shanghai Heartcare Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2023-12-22
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.