Clearance Summary
NICOLET VASOGUARD received FDA 510(k) clearance under submission number K002766, sponsored by Nicolet Biomedical. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-11-30.
- Submission: K002766
- Applicant / Sponsor: Nicolet Biomedical
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2880
- Decision date: 2000-11-30
Classification & Regulation
This clearance is catalogued under FDA product code JOP and 21 CFR 870.2880, within the Cardiovascular review panel as a Class II device.