Clearance Summary
HawkOne Directional Atherectomy System received FDA 510(k) clearance under submission number K161361, sponsored by Medtronic Vascular, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-10-14.
- Submission: K161361
- Applicant / Sponsor: Medtronic Vascular, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4875
- Decision date: 2016-10-14
Classification & Regulation
This clearance is catalogued under FDA product code MCW and 21 CFR 870.4875, within the Cardiovascular review panel as a Class II device.