Clearance Summary
AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS received FDA 510(k) clearance under submission number K110793, sponsored by Ameco Medical Industries. 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 2011-12-16.
- Submission: K110793
- Applicant / Sponsor: Ameco Medical Industries
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2011-12-16
Classification & Regulation
This clearance is catalogued under FDA product code MPB and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.