Clearance Summary
VAS-CATH PERITONEAL DIALYSIS CATHETER received FDA 510(k) clearance under submission number K871817, sponsored by Vas-Cath of Canada , Ltd.. 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 1987-07-16.
- Submission: K871817
- Applicant / Sponsor: Vas-Cath of Canada , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1987-07-16
Classification & Regulation
This clearance is catalogued under FDA product code FJS and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.