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selectra 7f catheters
Biotronik
Summary: The Selectra 7F Catheters by Biotronik are used in venous stenting procedures. They are primarily utilized by interventional cardiologists and radiologists for patients requiring venous access and intervention.
FDA Clearance Information
Pathway
510K
Number
K123324 ↗
Decision Date
January 11, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra 7F Catheters, manufactured by Biotronik, were cleared through the FDA 510(k) pathway on January 11, 2013. It is a Class 2 medical device under the product code DQY.
What It Is
The Selectra 7F Catheters are specialized medical devices designed for use in venous stenting procedures. These catheters allow for precise placement and deployment of stents within the venous system. They are engineered to provide flexibility and support during navigation through the venous anatomy, ensuring optimal stent placement.
Clinical Applications
Selectra 7F Catheters are commonly used in interventional cardiology and radiology settings. They are employed in procedures requiring venous access, such as treating venous obstructions or insufficiencies. These catheters are particularly useful in patients with conditions like deep vein thrombosis or chronic venous insufficiency, where stenting can help restore proper blood flow.
Indications for Use
The FDA-cleared indications for the Selectra 7F Catheters include use in procedures that require venous stenting. This means they are suitable for patients needing intervention to address venous blockages or structural issues within the venous system.
Practical Considerations
The Selectra 7F Catheters are typically available in various lengths and configurations to accommodate different patient anatomies and procedural needs. They are compatible with standard stenting equipment and require careful handling to ensure precise stent deployment.
Frequently Asked Questions
What is Selectra 7F Catheters used for?
Selectra 7F Catheters are used for venous stenting procedures, providing access and support for stent placement in the venous system.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include use in venous stenting procedures to address blockages or structural issues in the venous system.
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.