# K983154: Cystic Duct Balloon Dilating Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: May 5, 1999 after 238 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Cook Guided Biliary Dilator Set: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K929224: Applied Medical Obturator (dilator). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The Applied Medical Cystic Duct Balloon Dilating Catheter is indicated for dilating narrowed or obstructed ducts in the biliary tree to allow access for diagnostic or surgical procedures.

Source page: https://510kreport.com/device/K983154
Methodology: https://510kreport.com/methodology