Clearance Summary
Arterial Catheter received FDA 510(k) clearance under submission number K201726, sponsored by Haolang Medical USA Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-07-07.
- Submission: K201726
- Applicant / Sponsor: Haolang Medical USA Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2021-07-07
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.