Clearance Summary
DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 received FDA 510(k) clearance under submission number K971753, sponsored by Denver Biomaterials, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-06-27.
- Submission: K971753
- Applicant / Sponsor: Denver Biomaterials, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5050
- Decision date: 1997-06-27
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.