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enabler-p catheter system model 3000
Endocross
Summary: The Enabler-P Catheter System Model 3000 by Endocross is a medical device used in venous stenting procedures. It is primarily utilized by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K092174 ↗
Decision Date
December 30, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Enabler-P Catheter System received FDA clearance through the 510(k) pathway on December 30, 2009. Manufactured by Endocross, it is classified as a Class 2 device under product code DQY.
What It Is
The Enabler-P Catheter System is a specialized catheter designed to facilitate the placement of venous stents. It operates by providing a conduit for the delivery of stents to targeted venous sites, aiding in the treatment of venous obstructions. This system is crucial in ensuring precise stent deployment, which is vital for restoring proper venous blood flow.
Clinical Applications
The Enabler-P Catheter System is commonly used in procedures addressing venous stenosis or occlusions, often seen in patients with chronic venous insufficiency or post-thrombotic syndrome. Interventional radiologists and vascular surgeons typically employ this device in hospital settings, particularly in catheterization labs. It is suitable for adult patients who require venous stenting to alleviate symptoms related to impaired venous drainage.
Indications for Use
The FDA indications for the Enabler-P Catheter System involve its use in the placement of venous stents to treat conditions like venous obstructions. This device is indicated for patients experiencing symptoms due to narrowed or blocked veins, often in the context of chronic venous diseases.
Practical Considerations
The Enabler-P Catheter System is compatible with a range of stent sizes, making it versatile for different patient anatomies. Clinicians should be familiar with catheter manipulation techniques to ensure accurate stent placement. It is important to verify compatibility with other interventional tools used during the procedure.
Frequently Asked Questions
What is the Enabler-P Catheter System used for?
It 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.
What are the FDA-cleared indications?
The device is indicated for use in placing venous stents to treat venous obstructions.
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.