Modification to Paramount Mini Stent and Delivery System
FDA 510(k)Class II (US FDA 510(k))
by Ev3, Inc
Identifiers
- 510(k) Number
- K033134 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)
This device is a modification to the Paramount Mini Stent and Delivery System, classified as a stent, drain, or dilator for the biliary ducts. It is intended as a palliative treatment for malignant neoplasms in the biliary tree.
The device is supplied by Ev3, Inc. and received FDA 510(k) clearance under K033134. It is a Class II device subject to special controls, with product code FGE and regulation number 876.5010. The device is used in gastroenterology and urology settings.
Frequently asked questions
What is the Modification to Paramount Mini Stent and Delivery System used for?
It is intended as a palliative treatment for malignant neoplasms in the biliary tree, functioning as a stent, drain, or dilator in the biliary ducts to relieve obstruction in gastroenterology and urology settings.
How is the Modification to Paramount Mini Stent and Delivery System supplied and by whom?
The device is supplied by Ev3, Inc. from their facility in Plymouth, Minnesota, and was cleared via FDA 510(k) submission K033134 on November 17, 2003.
Is the Modification to Paramount Mini Stent and Delivery System a single-use or reusable device?
Although not explicitly stated in the provided data, biliary stents like this modification are typically designed for single-use implantation due to infection risks and material degradation, consistent with standard clinical practice for palliative biliary stenting.
What regulatory classification and product code apply to this device?
It is classified as a Class II medical device under regulation number 876.5010 with product code FGE, falling under the category of stents, drains, and dilators for the biliary ducts, and is subject to special controls.
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: fda.innolitics.com, K033134 - Modification to Paramount Mini Stent An..., fda.innolitics.com, K033134 - Modification to Paramount Mini Stent An...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033134 | Class II | Active |
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Manufacturer
- Manufacturer
- Ev3, Inc
- FDA Applicant
- Ev3, Inc.
Sources (1)
- FDA 510(k) K033134 24 fields · synced Sep 26, 2026