Clearance Summary
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS received FDA 510(k) clearance under submission number K051711, sponsored by Denver Biomedical, 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 2005-11-15.
- Submission: K051711
- Applicant / Sponsor: Denver Biomedical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 2005-11-15
Classification & Regulation
This clearance is catalogued under FDA product code PNG and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.