# K180485: Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jul 27, 2018 after 154 days
- Product code: FJS (Catheter, Peritoneal, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K823331 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071167: Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560, Medigroup, Inc. (2007) Summary page 5.

## Indications for use
The peritoneal catheter is indicated for acute and chronic peritoneal dialysis. The peritoneal dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques. The presternal peritoneal catheter is indicated for acute and chronic peritoneal dialysis. The Peritoneal Dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques. The Two Part Titanium Luer Adapter is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter. The Two Part Titanium Luer Adapter is designed to provide a permanent threaded closure when used with a standard continuous ambulatory peritoneal dialysis (CAPD) transfer set. The Titanium Catheter Extender is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter. The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.

Source page: https://510kreport.com/device/K180485
Methodology: https://510kreport.com/methodology