# K970041: Ascend Balloon Dailation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Mar 19, 1997 after 72 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 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) Balloon Dilation Catheters manufactured by Bard: named in the summary without a submission number
- (no number) High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive: named in the summary without a submission number

## Most influential descendants
- K072749: Sialo Balloon Dilatation Catheter (2008), 1 descendant of its own
- K172588: Balloon Catheter and Balloon Ureteral Dilator Set (2018), 0 descendants of its own
- K140593: Advance Salivary Balloon Catheter with Wire Guide (2014), 0 descendants of its own
- K040127: Cook Ureteral Balloon Dilation Catheter Set (2004), 0 descendants of its own

## Indications for use
The Ascend™ Balloon Dilation Catheter is used for ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter.

Source page: https://510kreport.com/device/K970041
Methodology: https://510kreport.com/methodology