Clearance Summary
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES received FDA 510(k) clearance under submission number K042297, sponsored by Acta Vascular Systems, 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 2005-06-01.
- Submission: K042297
- Applicant / Sponsor: Acta Vascular Systems, Inc.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 2005-06-01
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.