Clearance Summary
P-S MEDICAL CSF-FLOW CONTROL VALVE- received FDA 510(k) clearance under submission number K841442, sponsored by P-S Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1984-04-19.
- Submission: K841442
- Applicant / Sponsor: P-S Medical
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5550
- Decision date: 1984-04-19
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.