Clearance Summary
HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 received FDA 510(k) clearance under submission number K091458, sponsored by Ev3 Neurovascular. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-10-15.
- Submission: K091458
- Applicant / Sponsor: Ev3 Neurovascular
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2009-10-15
Classification & Regulation
This clearance is catalogued under FDA product code MJN and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.