Clearance Summary
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 received FDA 510(k) clearance under submission number K063431, 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 2007-01-29.
- Submission: K063431
- Applicant / Sponsor: Spire Biomedical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2007-01-29
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.