Tenckhoff Peritoneal Catheters
by Quinton, Inc. 510(k)
Active
510(k) K812607
Overview
Tenckhoff Peritoneal Catheters are peritoneal catheters designed for long-term indwelling use. They are classified as Class II medical devices under product code FJS and regulation number 876.5630.
These catheters are supplied by Quinton, Inc. and were cleared via the FDA 510(k) pathway under K812607 on October 2, 1981. They are indicated for use in gastroenterology and urology applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812607 | Date2 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- Withdrawn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
Other devices from Quinton, Inc.
Questions
What is the Tenckhoff Peritoneal Catheter used for?
The Tenckhoff Peritoneal Catheter is designed for long-term indwelling use in peritoneal dialysis and is indicated for gastroenterology and urology applications, allowing sustained access to the peritoneal cavity for fluid exchange.
How is the Tenckhoff Peritoneal Catheter supplied and is it sterile?
The catheter is supplied by Quinton, Inc. as a sterile, single-use device intended for long-term implantation; it is not reusable and must be discarded after removal to prevent infection and ensure patient safety.
What regulatory pathway was used for the Tenckhoff Peritoneal Catheter?
The device was cleared through the FDA 510(k) traditional pathway under submission K812607, which was received on September 15, 1981, and cleared on October 2, 1981, demonstrating substantial equivalence to a legally marketed predicate device.