📋 FDA Reference
Model 9210 Delivery Catheter Model 9210
Medtronic Vascular
Summary: The Model 9210 Delivery Catheter by Medtronic Vascular is a device used for the placement of venous stents. It is primarily used by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013963 ↗
Decision Date ?
February 28, 2002
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Model 9210 Delivery Catheter was cleared through the FDA 510(k) pathway on February 28, 2002. It is manufactured by Medtronic Vascular and classified as a Class II device under product code DQY.
What It Is
The Model 9210 Delivery Catheter is a medical device designed to facilitate the delivery and placement of venous stents. It is typically used in minimally invasive procedures to treat venous obstructions by providing a pathway for stent deployment. The catheter is engineered to navigate through the venous system, ensuring precise placement of the stent at the target site.
FDA-Cleared Indications
- Delivery and placement of compatible venous stents.
- Use in percutaneous treatment procedures involving venous obstruction, when a compatible venous stent is indicated.
Clinical Applications
- Percutaneous delivery of a compatible stent to an obstructed venous segment.
- Positioning and deployment of a venous stent to help restore venous lumen patency.
- Catheter-based venous stent placement in the iliac or central venous system when consistent with the applicable stent labeling.
Practical Considerations
- Confirm compatibility between the Model 9210 catheter, the selected venous stent, guidewire, and delivery system before the procedure.
- Select the catheter and stent dimensions appropriate for the target vessel and access route; the available size range should be confirmed in the device labeling.
- The catheter is advanced percutaneously under imaging guidance, commonly through femoral or another suitable venous access site.
- Use requires familiarity with venous anatomy, catheter handling, stent deployment, and management of access-site or vessel complications.
- MRI safety and conditions should be verified in the current device labeling; do not assume MRI compatibility from the catheter name alone.
Procedures that use this device
Frequently Asked Questions
What is the Model 9210 Delivery Catheter used for?
The Model 9210 Delivery Catheter is used for the delivery and placement of venous stents in patients with venous obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in procedures involving venous stent placement.
What are the FDA-cleared indications?
The FDA-cleared indications include the use of the catheter for placing venous stents to treat venous obstructions and improve blood flow.
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.