Clearance Summary
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS received FDA 510(k) clearance under submission number K011831, sponsored by Denver Biomedical, 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 2001-06-28.
- Submission: K011831
- Applicant / Sponsor: Denver Biomedical, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5050
- Decision date: 2001-06-28
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.