Clearance Summary
VOYAGER PERITONEAL DIALYSIS SYSTEM received FDA 510(k) clearance under submission number K103220, sponsored by Deka Research & Development Corp.. 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 2011-07-29.
- Submission: K103220
- Applicant / Sponsor: Deka Research & Development Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 2011-07-29
Classification & Regulation
This clearance is catalogued under FDA product code FKX and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.