Clearance Summary
MIRAFLEX HIGH FLOW MICROCATHETER received FDA 510(k) clearance under submission number K080737, sponsored by Cook, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-08-08.
- Submission: K080737
- Applicant / Sponsor: Cook, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1210
- Decision date: 2008-08-08
Classification & Regulation
This clearance is catalogued under FDA product code KRA and 21 CFR 870.1210, within the Cardiovascular review panel as a Class II device.