# K050875: U-Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 26, 2005 after 50 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- 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® UroForce™ Balloon Dilation Catheter: named in the summary without a submission number

## Indications for use
The Bard® U-Balloon Dilation Catheter is indicated for dilation of the urinary tract.

Source page: https://510kreport.com/device/K050875
Methodology: https://510kreport.com/methodology