# K993840: Bard Uroforce Balloon Dilation Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 31, 2000 after 80 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Opti-Plast® Centurion™ 5.5F PTA Catheter: named in the summary without a submission number
- (no number) Bard® A-Trac Urological Balloon Dilation Catheter: named in the summary without a submission number

## Most influential descendants
- K201007: In-Ka Ureteral Balloon Dilatation Catheter (2020), 0 descendants of its own

## Recalls of this device
- Nov 3, 2005 · Not classified · Z-0268-06: There is a potential for the lumen to collapse and prevent passage over a guidewire.

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

Source page: https://510kreport.com/device/K993840
Methodology: https://510kreport.com/methodology