📋 FDA Reference
Selectra Catheters Selectra Accessory Kit
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 ?
510(k)
Number ?
K183265 ↗
Decision Date ?
December 13, 2018
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used for percutaneous catheter-based vascular access and navigation during an endovascular procedure.
- Use is limited to the specific catheter configurations, anatomy, and procedural applications described in the device's current FDA-cleared labeling and instructions for use.
Clinical Applications
- Obtaining or maintaining vascular access for catheter-based treatment.
- Supporting catheter navigation within the venous system when used according to the cleared configuration and instructions for use.
- Providing access during endovascular procedures in which additional catheter accessories are required.
Practical Considerations
- Select the catheter size, length, and configuration based on the access vessel, target anatomy, and other devices used during the procedure.
- Confirm compatibility with guidewires, introducer sheaths, stents, and other accessories before use.
- Use fluoroscopic or other appropriate imaging guidance and follow the manufacturer's instructions for preparation, advancement, and removal.
- Review the labeling for contraindications, vascular injury risks, maximum pressure limits, and any MRI conditions; MRI safety should not be assumed from the FDA clearance alone.
- The kit is generally intended for single-use procedures unless the current labeling states otherwise; do not reuse or resterilize a device labeled single use.
Procedures that use this device
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.