Peritoneal Catheter-Changes
by Quinton, Inc. 510(k)
Active
510(k) K833749
Overview
A peritoneal catheter is a system for automatic delivery used in gastroenterology and urology. It is designed for peritoneal access and fluid management.
The device received FDA 510(k) clearance (K833749) on December 27, 1983, as substantially equivalent to a predicate device. It is manufactured by Quinton, Inc. in McHenry, Illinois, and is classified as a Class II medical device under regulation number 876.5630 with product code FKX.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833749 | Date27 Dec 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FKX
- 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 PERITONEAL CATHETER-CHANGES- used for?
The PERITONEAL CATHETER-CHANGES- is a peritoneal catheter system designed for automatic delivery, providing peritoneal access and fluid management in gastroenterology and urology applications, as indicated in its FDA 510(k) clearance documentation.
How was the PERITONEAL CATHETER-CHANGES- cleared for market?
The device received FDA 510(k) clearance under K833749 on December 27, 1983, as substantially equivalent to a predicate device, following a traditional review pathway and classified as a Class II medical device under regulation 876.5630 with product code FKX.
Who manufactures the PERITONEAL CATHETER-CHANGES- and where is it made?
The PERITONEAL CATHETER-CHANGES- is manufactured by Quinton, Inc. in McHenry, Illinois, United States, as specified in the device’s authorization and establishment registration details.