Clearance Summary
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE received FDA 510(k) clearance under submission number K051084, sponsored by Denver Biomedicals, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-06-13.
- Submission: K051084
- Applicant / Sponsor: Denver Biomedicals, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5050
- Decision date: 2005-06-13
Classification & Regulation
This clearance is catalogued under FDA product code DWM and 21 CFR 870.5050, within the Cardiovascular review panel as a Class II device.