Clearance Summary
WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE received FDA 510(k) clearance under submission number K961797, sponsored by Wright Linear Pump, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1996-11-06.
- Submission: K961797
- Applicant / Sponsor: Wright Linear Pump, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 1996-11-06
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.