Clearance Summary
PERITONEAL DIALYSIS CATHETER received FDA 510(k) clearance under submission number K771555, sponsored by Fluoro-Mold Co.. 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 1977-11-28.
- Submission: K771555
- Applicant / Sponsor: Fluoro-Mold Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1977-11-28
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.