Clearance Summary
FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER received FDA 510(k) clearance under submission number K895506, sponsored by Vas-Cath, 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 1990-02-09.
- Submission: K895506
- Applicant / Sponsor: Vas-Cath, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 1990-02-09
Classification & Regulation
This clearance is catalogued under FDA product code LFJ and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.