# K863437: Bard Balloon Dilatation System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 29, 1986 after 54 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
No predicates in its family tree.
47 later devices descend from it; 2 cite it directly.
0 of 48 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
- K940965: Eliminator Balloon Dilator (1994), 44 descendants of its own
- 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

Source page: https://510kreport.com/device/K863437
Methodology: https://510kreport.com/methodology