# K940965: Eliminator Balloon Dilator

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 20, 1994 after 79 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863437 (1986). 1 ancestor in all.
44 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863437: Bard Balloon Dilatation System, C.R. Bard, Inc. (1986) Summary page 1.
- (no number) Microvasive Achiever™: named in the summary without a submission number

## Most influential descendants
- K023765: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) (2002), 42 descendants of its own
- K013139: Stellartech Coagulation System (2001), 42 descendants of its own
- K032062: Stellartech Coagulation System, Models  (1100C-115 & 1100C-230) (2003), 41 descendants of its own
- K032452: Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 (2003), 39 descendants of its own
- K032721: Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) (2003), 38 descendants of its own

## Indications for use
The Bard® Balloon Dilator is intended to be used for dilatation of strictures of the gastrointestinal tract, but not limited to strictures of the esophagus, pylorus, duodenum, sphincter of Oddi, biliary tree and colon.

Source page: https://510kreport.com/device/K940965
Methodology: https://510kreport.com/methodology