# K180781: Bard Vertus Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 19, 2018 after 177 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- 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: 2 generations back to K910195 (1991). 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)
- K150699: Bard LubriGuard Foley Catheter, C.R. Bard, Inc. (2015) Summary page 5.

## Indications for use
The BARD® VertusTM Foley Catheter is indicated for use in the drainage and/or collection and/or measurement of urine in adult and pediatric patients of compatible anatomical size. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.

Source page: https://510kreport.com/device/K180781
Methodology: https://510kreport.com/methodology