Clearance Summary
MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS received FDA 510(k) clearance under submission number K111490, sponsored by Ev3, 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 2011-09-16.
- Submission: K111490
- Applicant / Sponsor: Ev3, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1210
- Decision date: 2011-09-16
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.