Clearance Summary
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER received FDA 510(k) clearance under submission number K102605, sponsored by Covidien, LLC, Formerly Registered AS Tyco Healthca. 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 2010-12-22.
- Submission: K102605
- Applicant / Sponsor: Covidien, LLC, Formerly Registered AS Tyco Healthca
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2010-12-22
Classification & Regulation
This clearance is catalogued under FDA product code NIE and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.