Clearance Summary
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER received FDA 510(k) clearance under submission number K122422, sponsored by Care Fusion. 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 2012-10-24.
- Submission: K122422
- Applicant / Sponsor: Care Fusion
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 2012-10-24
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.