# K140593: Advance Salivary Balloon Catheter with Wire Guide

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Dec 15, 2014 after 283 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970041 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072749: Sialo Balloon Dilatation Catheter, Sialo Technology, Ltd. (2008) Summary page 4.
- K122940: Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3, Cook, Inc. (2013) Summary page 4.
- K011084: Mandrel Guidewire Assembly, Lake Region Mfg., Inc. (2001) Summary page 5.

## Indications for use
The Advance® Salivary Balloon Catheter is intended for the dilation of lesions and strictures in the submandibular and parotid salivary ducts.

Source page: https://510kreport.com/device/K140593
Methodology: https://510kreport.com/methodology