Clearance Summary
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER received FDA 510(k) clearance under submission number K002627, sponsored by Atrium Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-04-26.
- Submission: K002627
- Applicant / Sponsor: Atrium Medical Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 2001-04-26
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.