Clearance Summary
MODIFICATION TO VAXCEL DIALYSIS CATHETER received FDA 510(k) clearance under submission number K012948, sponsored by Boston Scientific/Medi-Tech. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-10-03.
- Submission: K012948
- Applicant / Sponsor: Boston Scientific/Medi-Tech
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2001-10-03
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.