Clearance Summary
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER received FDA 510(k) clearance under submission number K130039, sponsored by Gambro Renal Products, Inc.. 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 2013-05-02.
- Submission: K130039
- Applicant / Sponsor: Gambro Renal Products, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2013-05-02
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.