Clearance Summary
M-BOLUS EMBOLIC MICROSPHERES received FDA 510(k) clearance under submission number K052509, sponsored by Scion Cardio-Vascular, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-12-11.
- Submission: K052509
- Applicant / Sponsor: Scion Cardio-Vascular, Inc.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 2006-12-11
Classification & Regulation
This clearance is catalogued under FDA product code HCG and 21 CFR 882.5950, within the Neurology review panel as a Class II device.