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enabler-p catheter 1000 part number 1160
Endocross
Summary: The Enabler-P Catheter 1000, manufactured by Endocross, is a medical device used in venous stenting procedures. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K083833 ↗
Decision Date
May 22, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Enabler-P Catheter 1000 was cleared through the FDA 510(k) pathway on May 22, 2009. It is manufactured by Endocross and classified as a Class 2 device under product code DQY.
What It Is
The Enabler-P Catheter 1000 is a specialized catheter designed to assist in the placement of venous stents. It facilitates the navigation and deployment of stents within the venous system, helping to restore proper blood flow in patients with venous obstructions. The catheter's design allows for precise control and maneuverability, which is crucial during stenting procedures.
Clinical Applications
This device is commonly used in procedures involving the placement of stents in the venous system, particularly in cases of venous stenosis or occlusion. It is frequently employed in interventional radiology and vascular surgery settings. Patients who may benefit from this device include those with chronic venous insufficiency or post-thrombotic syndrome, where stenting can alleviate symptoms and improve venous circulation.
Indications for Use
The FDA indications for the Enabler-P Catheter 1000 include its use in procedures requiring venous stenting. It is intended for patients with conditions that cause narrowing or blockage of the veins, where stenting can help restore normal blood flow.
Practical Considerations
The Enabler-P Catheter 1000 is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard stenting equipment and techniques, ensuring ease of integration into existing procedural workflows. Clinicians should be familiar with catheter manipulation techniques to optimize outcomes.
Frequently Asked Questions
What is the Enabler-P Catheter 1000 used for?
It is used for assisting in the placement of venous stents to treat venous obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting to treat vein narrowing or blockage.
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.