# K962921: Bard a-Trac Urological Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 9, 1996 after 75 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® Tru-Trac™ Peripheral Balloon Dilatation Catheters: named in the summary without a submission number
- (no number) Microvasive's (Boston Scientific Corporation) Uro Max™ II High Pressure Ureteral Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) Phantom 5™ Plus ST (Short Tip) Ureteral Balloon Dilatation Catheter: named in the summary without a submission number

## Indications for use
Indicated for use in dilation of the ureter or urethra through the working channel of an endoscope.

Source page: https://510kreport.com/device/K962921
Methodology: https://510kreport.com/methodology