Clearance Summary
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter received FDA 510(k) clearance under submission number K202049, sponsored by Applied Medical Resources Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-09-07.
- Submission: K202049
- Applicant / Sponsor: Applied Medical Resources Corporation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 2021-09-07
Classification & Regulation
This clearance is catalogued under FDA product code DXE and 21 CFR 870.5150, within the Cardiovascular review panel as a Class II device.