# K983101: Bardex I.C 4-Way Foley Catheter Model 1865SIXX XX = 18,20,22,24

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 3, 1998 after 61 days
- Product code: MJC (Catheter, Urological (Antimicrobial) And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K922431 (1993). 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)
- K922431: Bard Latex Urinary Catheters, C.R. Bard, Inc. (1993) Summary page 2.
- K910318: Bard (R) Hydrogel/Silver-Coated Foley Catheter, C.R. Bard, Inc. (1994) Summary page 2.

## Indications for use
The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate.

Source page: https://510kreport.com/device/K983101
Methodology: https://510kreport.com/methodology