Cuff Material on Pediatric Size Cath
by Quinton, Inc. 510(k)
Active
510(k) K812718
Overview
The device is a peritoneal long‑term indwelling catheter designed with cuff material for pediatric use. It provides a conduit for continuous peritoneal dialysis or fluid drainage in children, incorporating a cuff to promote tissue ingrowth and secure placement.
The catheter is classified as a Class II medical device and received FDA 510(k) clearance (K812718) under product code FJS. It is supplied in a pediatric size, identified by the manufacturer Quinton, Inc., and is regulated as a medical device in the United States.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812718 | Date19 Oct 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FJS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent