Clearance Summary
LOW FLOW OSV II HYDROCEPHALUS VALVE received FDA 510(k) clearance under submission number K042192, sponsored by Integra Neurosciences Implants S.A.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-09-02.
- Submission: K042192
- Applicant / Sponsor: Integra Neurosciences Implants S.A.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5550
- Decision date: 2004-09-02
Classification & Regulation
This clearance is catalogued under FDA product code JXG and 21 CFR 882.5550, within the Neurology review panel as a Class II device.