Clearance Summary
TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 received FDA 510(k) clearance under submission number K062870, sponsored by Kensey Nash Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-10-20.
- Submission: K062870
- Applicant / Sponsor: Kensey Nash Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2006-10-20
Classification & Regulation
This clearance is catalogued under FDA product code NFA and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.