Clearance Summary
FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH received FDA 510(k) clearance under submission number K032884, sponsored by Boston Scientific Epi. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-08-06.
- Submission: K032884
- Applicant / Sponsor: Boston Scientific Epi
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2004-08-06
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.