Clearance Summary
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS received FDA 510(k) clearance under submission number K042858, sponsored by Spire Biomedical, Inc.. 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 2004-12-03.
- Submission: K042858
- Applicant / Sponsor: Spire Biomedical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2004-12-03
Classification & Regulation
This clearance is catalogued under FDA product code MSD and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.