Clearance Summary
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER received FDA 510(k) clearance under submission number K012235, sponsored by Denver Biomedical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-10-04.
- Submission: K012235
- Applicant / Sponsor: Denver Biomedical, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5955
- Decision date: 2001-10-04
Classification & Regulation
This clearance is catalogued under FDA product code KPM and 21 CFR 876.5955, within the Gastroenterology, Urology review panel as a Class II device.