Clearance Summary
M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER received FDA 510(k) clearance under submission number K112100, sponsored by Vascular Solutions, 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 2012-03-20.
- Submission: K112100
- Applicant / Sponsor: Vascular Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2012-03-20
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.