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selectra catheters selectra accessory kit
Biotronik
Summary: The Selectra Catheters by Biotronik are used for venous access in procedures involving venous stents. They are typically utilized by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K183265 ↗
Decision Date
December 13, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra Catheters were cleared through the FDA 510(k) pathway on December 13, 2018. Manufactured by Biotronik, this Class 2 device is categorized under product code DQY.
What It Is
The Selectra Catheters are medical devices designed to facilitate venous access for the placement of stents. They are part of an accessory kit that includes components to assist in the navigation and delivery of stents within the venous system. These catheters are engineered to provide precise control and stability during procedures.
Clinical Applications
Selectra Catheters are commonly used in interventional cardiology and radiology settings, particularly in procedures requiring the placement of venous stents. They are suitable for use in hospitals and specialized clinics, often involving patients with venous obstructions or those requiring venous reconstruction. The device is essential for ensuring accurate stent positioning in complex vascular anatomies.
Indications for Use
The FDA indications for the Selectra Catheters involve their use in procedures requiring venous stenting. They are intended for patients with conditions that necessitate the placement of stents to maintain or restore venous patency.
Practical Considerations
Selectra Catheters come in various sizes to accommodate different patient anatomies and procedural requirements. They are compatible with standard stenting equipment and require careful handling to ensure optimal performance. Clinicians should be familiar with the catheter's specifications for successful integration into procedural workflows.
Frequently Asked Questions
What is Selectra Catheters used for?
Selectra Catheters are used for venous access and the delivery of stents in procedures requiring venous stenting.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use Selectra Catheters in their procedures.
What are the FDA-cleared indications?
The FDA-cleared indications involve the use of Selectra Catheters for procedures requiring the placement of venous stents.
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.