# K053123: PD Cath

- Pathway: 510(k) (Traditional)
- Applicant: Med-Conduit, Inc.
- Decided: Mar 29, 2006 after 142 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: 1 generation back to K874650 (1987). 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)
- K894131: Dermaport Vascular Access Device Model NO. 50-1000, Thermedics, Inc. (1989) Summary page 1.
- K874650: Peritoneal Dialysis Kit (Acute and Chronic Form), Quinton, Inc. (1987) Summary page 1.

## Indications for use
The PD Cath is indicated for use in attaining long term peritoneal access for peritoneal dialysis. The catheter is intended for implantation dwell time of greater than 30 days.

Source page: https://510kreport.com/device/K053123
Methodology: https://510kreport.com/methodology