📋 FDA Reference
Selectra 7f Catheters
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 ?
510(k)
Number ?
K123324 ↗
Decision Date ?
January 11, 2013
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- For percutaneous catheter use during endovascular procedures, as described under FDA product code DQY.
- The available FDA summary does not provide a more specific disease, vessel, or treatment indication.
Clinical Applications
- Percutaneous vascular access during endovascular intervention.
- Catheter-based delivery or positioning of compatible interventional devices when permitted by the product labeling.
- Use in venous interventions when the selected catheter configuration and labeling support the procedure.
Practical Considerations
- The catheter is identified as 7 French; available lengths, curves, lumens, and other configurations should be confirmed in the current manufacturer instructions for use.
- Compatibility with guidewires, sheaths, contrast media, stents, and other devices must be checked before the procedure.
- Use requires fluoroscopic or other appropriate imaging guidance, sterile technique, and trained procedural personnel.
- MRI safety is configuration-specific. Confirm the current labeling for the exact catheter and whether it is MR Safe, MR Conditional, or not established before MRI.
- Potential contraindications and risks include vessel injury, bleeding, infection, thrombosis, embolization, contrast reaction, and inability to advance or retrieve the catheter; follow the current instructions for use.
Procedures that use this device
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.