# K952968: Dilatation Catheter, Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 10, 1995 after 44 days
- Product code: LJE (Catheter, Nephrostomy)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K121614: Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter (2012), 8 descendants of its own
- K130804: Uromax Ultra Balloon Dilatation Catheter (2013), 4 descendants of its own
- K171601: Ultraxx Nephrostomy Balloon Catheter (2018), 1 descendant 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

Source page: https://510kreport.com/device/K952968
Methodology: https://510kreport.com/methodology