# K980795: Urological Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 22, 1998 after 51 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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 no predicate by number.

## Most influential descendants
- K130804: Uromax Ultra Balloon Dilatation Catheter (2013), 4 descendants of its own
- K250910: Optilume® High Pressure Urological Balloon Dilation Catheter (2025), 0 descendants of its own
- K191061: Optilume Basic Urological Balloon Dilation Catheter (2020), 0 descendants of its own
- K190612: EQUINOX Balloon Dilatation Catheter (2019), 0 descendants of its own
- K132181: Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation Catheter (2013), 0 descendants of its own

## Indications for use
BD-3 Catheters are intended for urological dilatation; ureteral and urethral.

Source page: https://510kreport.com/device/K980795
Methodology: https://510kreport.com/methodology