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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
510K
Number
K013963 ↗
Decision Date
February 28, 2002
Product Code
DQY
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.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for patients with venous insufficiency or obstructions. It is particularly useful in procedures where stent placement is required to restore venous flow, such as in cases of deep vein thrombosis or chronic venous occlusions. The catheter is suitable for use in both hospital and outpatient settings, catering to adult and geriatric patient populations.
Indications for Use
The FDA-cleared indications for the Model 9210 Delivery Catheter include its use in the placement of venous stents to treat conditions like venous obstructions. It is intended for patients who require stent placement to improve venous blood flow and alleviate symptoms associated with venous insufficiency.
Practical Considerations
Clinicians should consider the compatibility of the catheter with the specific stent being used, as well as the size of the venous anatomy. Proper technique in navigating the catheter through the venous system is crucial for successful stent placement. Familiarity with the device's handling characteristics can enhance procedural efficiency.
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.