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gopher gold catheter model 5620
Vascular Solutions
Summary: The Gopher Gold Catheter Model 5620 is a medical device used for venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K091345 ↗
Decision Date
June 12, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Gopher Gold Catheter Model 5620 was cleared through the FDA 510k pathway on June 12, 2009. Manufactured by Vascular Solutions, it is classified as a Class 2 device under product code DQY.
What It Is
The Gopher Gold Catheter Model 5620 is a specialized catheter designed for use in venous stenting procedures. It facilitates the placement of stents within veins to restore or maintain adequate blood flow. The catheter is engineered to navigate the venous system efficiently, providing support for the deployment of stents in targeted areas.
Clinical Applications
This device is commonly used in procedures addressing venous obstructions, such as those caused by chronic venous insufficiency or post-thrombotic syndrome. Interventional radiologists and vascular surgeons often use it in hospital settings or specialized outpatient centers. It is particularly beneficial for patients with conditions that impede venous blood flow, requiring precise stent placement to alleviate symptoms.
Indications for Use
The FDA-cleared indications for the Gopher Gold Catheter include its use in procedures that require venous stenting to treat obstructions. It is intended for patients who have conditions that lead to narrowed or blocked veins, necessitating intervention to restore proper blood flow.
Practical Considerations
The Gopher Gold Catheter Model 5620 is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard stenting equipment and requires familiarity with venous access techniques. Proper handling and navigation are crucial for optimal outcomes.
Frequently Asked Questions
What is the Gopher Gold Catheter Model 5620 used for?
It is used for venous stenting procedures to treat obstructions in the venous system.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting to treat obstructions in veins.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.