Clearance Summary
KODAMA INTRAVASCULAR ULRASOUND CATHETER received FDA 510(k) clearance under submission number K113008, sponsored by Silicon Vally Medical Instruments, 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 2012-06-14.
- Submission: K113008
- Applicant / Sponsor: Silicon Vally Medical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2012-06-14
Classification & Regulation
This clearance is catalogued under FDA product code OBJ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.