Clearance Summary
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH received FDA 510(k) clearance under submission number K052480, sponsored by Hansen Medical, 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 2007-05-02.
- Submission: K052480
- Applicant / Sponsor: Hansen Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1290
- Decision date: 2007-05-02
Classification & Regulation
This clearance is catalogued under FDA product code DXX and 21 CFR 870.1290, within the Cardiovascular review panel as a Class II device.