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selectra 3d outer guiding catheters
Biotronik
Summary: The Selectra 3D Outer Guiding Catheters by Biotronik are used in venous interventions, primarily by interventional cardiologists and radiologists. They facilitate the placement of other devices in venous procedures.
FDA Clearance Information
Pathway
510K
Number
K193474 ↗
Decision Date
October 16, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra 3D Outer Guiding Catheters were cleared through the FDA 510(k) pathway on October 16, 2020. Manufactured by Biotronik, they are classified as Class 2 devices.
What It Is
The Selectra 3D Outer Guiding Catheters are specialized catheters designed to provide support and guidance for the insertion of other devices during venous interventions. They are engineered to navigate the venous system with precision, offering flexibility and stability. These catheters are crucial in procedures requiring the placement of stents or other therapeutic devices within the venous system.
Clinical Applications
These catheters are commonly used in interventional cardiology and radiology settings for procedures involving the placement of venous stents. They are particularly useful in treating patients with venous obstructions or anomalies. The device is suitable for use in hospitals and specialized clinics, primarily for adult patients requiring venous interventions.
Indications for Use
The FDA indications suggest that the Selectra 3D Outer Guiding Catheters are intended for use in procedures that require the placement of devices within the venous system. They are suitable for patients with conditions necessitating venous stenting or similar interventions.
Practical Considerations
These catheters are available in various sizes to accommodate different patient anatomies and procedural needs. They are compatible with standard interventional equipment and require skilled handling to ensure optimal placement and function during procedures.
Frequently Asked Questions
What is Selectra 3D Outer Guiding Catheters used for?
They are used to guide and support the placement of devices in venous interventions, such as stenting.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use these catheters.
What are the FDA-cleared indications?
The catheters are indicated for use in procedures requiring device placement in the venous system, such as venous stenting.
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.