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sspc nxt delivery catheter
Centerpoint Systems
Summary: The SSPC NXT Delivery Catheter is a medical device used for the delivery of venous stents. It is primarily used by interventional radiologists and vascular surgeons in procedures involving venous access and stent placement.
FDA Clearance Information
Pathway
510K
Number
K243180 ↗
Decision Date
December 4, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The SSPC NXT Delivery Catheter, manufactured by Centerpoint Systems, received FDA clearance through the 510k pathway on December 4, 2024. It is classified as a Class 2 device under product code DQY.
What It Is
The SSPC NXT Delivery Catheter is a specialized catheter designed for the precise delivery of venous stents. It features a flexible yet sturdy design to navigate the venous system and deploy stents accurately. This device is crucial in procedures requiring the reinforcement of venous structures, ensuring proper blood flow and reducing the risk of venous insufficiency.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings for patients requiring venous stenting. It is particularly useful in treating conditions such as chronic venous insufficiency, deep vein thrombosis, and post-thrombotic syndrome. The device is used in hospital settings, often in catheterization labs, where precise stent placement is critical.
Indications for Use
The SSPC NXT Delivery Catheter is indicated for use in patients who require venous stenting to address issues like blocked or narrowed veins. It is suitable for conditions that compromise venous blood flow, necessitating the placement of a stent to restore normal circulation.
Practical Considerations
Clinicians should be aware of the catheter's compatibility with various stent sizes and its flexibility, which aids in navigating complex venous anatomy. Proper technique in catheter manipulation is essential to ensure successful stent deployment and minimize complications.
Frequently Asked Questions
What is SSPC NXT Delivery Catheter used for?
It is used for the delivery and placement of venous stents in patients with conditions affecting venous blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in procedures involving venous stenting.
What are the FDA-cleared indications?
The device is indicated for use in delivering venous stents to treat conditions like venous insufficiency and deep vein thrombosis.
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.