Clearance Summary
Low Potassium Dextran Solution with Tris Diluent received FDA 510(k) clearance under submission number K153384, sponsored by United Therapeutics Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2016-02-19.
- Submission: K153384
- Applicant / Sponsor: United Therapeutics Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5880
- Decision date: 2016-02-19
Classification & Regulation
This clearance is catalogued under FDA product code KDN and 21 CFR 876.5880, within the Gastroenterology, Urology review panel as a Class II device.