Clearance Summary
MERCATOR MICROSYRINGE II INFUSION CATHETER received FDA 510(k) clearance under submission number K062752, sponsored by Mercator Medsystems, 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 2006-12-07.
- Submission: K062752
- Applicant / Sponsor: Mercator Medsystems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1210
- Decision date: 2006-12-07
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.