Bard Luminexx 6 Fr Biliary Stent And Delivery System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020682 FDA 510(k)
- FDA Product Code
- FGE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5010 FDA 510(k)
- Regulation Number
- 876.5010 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
The Bard Luminexx 6 Fr Biliary Stent And Delivery System is a medical device designed for use in the biliary ducts. It is a stent system intended to maintain patency in the biliary tract.
The device is supplied as a single-use system and is regulated under FDA 510K clearance. It is available in a 6 French size and is manufactured by C.R. Bard, Inc.
Frequently asked questions
What is the Bard Luminexx 6 Fr Biliary Stent and Delivery System used for?
The Bard Luminexx 6 Fr Biliary Stent and Delivery System is designed for use in the biliary ducts to maintain patency in the biliary tract. It is a stent system intended to help keep these ducts open and functioning properly.
How is the Bard Luminexx Biliary Stent supplied?
The Bard Luminexx 6 Fr Biliary Stent and Delivery System is supplied as a single-use system. This means it is designed for one patient use only and should not be reused or resterilized for another patient.
What is the regulatory status of the Bard Luminexx Biliary Stent?
The Bard Luminexx 6 Fr Biliary Stent and Delivery System is regulated under FDA 510K clearance, which means it has been determined to be substantially equivalent to legally marketed predicate devices for its intended use.
What sizes and models are available for the Bard Luminexx Biliary Stent?
The Bard Luminexx Biliary Stent is available in a 6 French size. This specific size is designed to accommodate the typical needs of biliary duct interventions while ensuring appropriate delivery and placement within the ductal system.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020682 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K020682 24 fields · synced Sep 21, 2026