Clearance Summary
SENSEI X ROBOTIC CATHETER SYSTEM received FDA 510(k) clearance under submission number K102168, sponsored by Hansen Medical, 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 2010-10-22.
- Submission: K102168
- Applicant / Sponsor: Hansen Medical, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1290
- Decision date: 2010-10-22
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.