# K213602: Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jan 14, 2022 after 60 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060897: Embedding Tool, Model TE-1000, Medigroup, Inc. (2006) Summary page 4.

## Indications for use
The Ritus™ tunneling tool kit is used to both create a tunnel tract through subcutaneous tissue and seal the end of the catheter. This allows the external portion of the Covidien™ peritoneal dialysis catheter to be temporarily buried in advance of dialysis for patients that are candidates for delayed peritoneal dialysis treatment.

Source page: https://510kreport.com/device/K213602
Methodology: https://510kreport.com/methodology