# K993464: Bardex I.C. Pediatric Foley Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 10, 1999 after 58 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard Hydrogel/Silver-Coated Foley Catheter: named in the summary without a submission number
- (no number) Bard Latex Urinary Catheters: named in the summary without a submission number
- (no number) Bard Hydrogel-Coated Foley Catheters: named in the summary without a submission number

## Indications for use
The Bardex 1. C. Pediatric Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Source page: https://510kreport.com/device/K993464
Methodology: https://510kreport.com/methodology