Clearance Summary
PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING received FDA 510(k) clearance under submission number K060509, sponsored by Tyco Healthcare Group. 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 2006-06-23.
- Submission: K060509
- Applicant / Sponsor: Tyco Healthcare Group
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2006-06-23
Classification & Regulation
This clearance is catalogued under FDA product code NYU and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.