đź“‹ FDA Reference
selectra catheters selectra accessory kit selectra slitter tool
Biotronik
Summary: The Selectra Catheters by Biotronik are used in venous stenting procedures. They are typically utilized by interventional cardiologists and vascular surgeons to facilitate the placement of stents in venous structures.
FDA Clearance Information
Pathway
510K
Number
K192996 ↗
Decision Date
November 21, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra Catheters were cleared through the FDA 510k pathway on November 21, 2019. Manufactured by Biotronik, this device is classified as Class 2 under product code DQY.
What It Is
The Selectra Catheters are medical devices designed to assist in the delivery and placement of stents within venous structures. These catheters are part of a kit that includes an accessory kit and a slitter tool, which are used to facilitate the procedure. The catheters are engineered to navigate the venous system efficiently, providing support and precision during stent deployment.
Clinical Applications
Selectra Catheters are commonly used in procedures involving venous stenting, particularly in cases of venous insufficiency or obstruction. They are frequently employed in interventional cardiology and vascular surgery settings. These devices are suitable for patients requiring venous stent placement, often in a hospital or specialized outpatient setting.
Indications for Use
The FDA-cleared indications for the Selectra Catheters involve their use in procedures requiring the placement of stents within the venous system. This includes patients with conditions such as venous obstructions or insufficiencies that necessitate stenting to restore proper blood flow.
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 precise placement. Clinicians should be familiar with the catheter's navigation and deployment techniques for optimal outcomes.
Frequently Asked Questions
What is Selectra Catheters used for?
Selectra Catheters are used for the delivery and placement of stents in venous structures during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use Selectra Catheters in venous stenting procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include the use of Selectra Catheters for stent placement in patients with venous obstructions or insufficiencies.
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.