Advance Salivary Balloon Catheter With Wire Guide
FDA 510(k)Class II (US FDA 510(k))
by Cook, Inc.
Identifiers
- 510(k) Number
- K140593 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Advance Salivary Balloon Catheter With Wire Guide is an over-the-wire, double-lumen catheter designed for the dilation of lesions and strictures in the submandibular and parotid salivary ducts. It features a catheter shaft constructed from polyimide, polyurethane, and PTFE with a hydrophilic coating and a nylon balloon located near the distal tip.
This device is supplied with a stainless steel mandrel wire guide. It has received FDA 510(k) clearance for its intended use. U.S. federal law restricts this device to sale by or on the order of a physician.
Frequently asked questions
What is the primary clinical use of the Advance Salivary Balloon Catheter?
This device is specifically designed for the dilation of lesions and strictures within the submandibular and parotid salivary ducts. It utilizes an over-the-wire, double-lumen design to facilitate access and treatment in these narrow anatomical structures.
What components are included with the catheter?
The device is supplied as a complete set including the double-lumen catheter shaft, which is constructed from polyimide, polyurethane, and PTFE with a hydrophilic coating, and a stainless steel mandrel wire guide to assist with placement.
Are there any restrictions on the sale of this device?
Yes, under U.S. federal law, this device is restricted to sale by or on the order of a physician. This ensures that the catheter is used only by qualified medical professionals who can appropriately manage the procedure.
What is the regulatory status of this salivary balloon catheter?
The Advance Salivary Balloon Catheter has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices for its intended use in salivary duct dilation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Advance® Salivary Duct Balloon Catheter Set - Cook Medical, Advance Salivary Balloon Catheter With Wire Guide (K140593) — Fda 510 ..., PDF Advance® Salivary Balloon Catheter With Wire Guide, PDF EN Salivary Balloon Catheter with Wire Guide DA Brugsanvisning DE
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140593 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA 510(k) K140593 24 fields · synced Sep 21, 2026