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attain prevail steerable catheter set model 6228cth
Medtronic Vascular
Summary: The Attain Prevail Steerable Catheter Set is a medical device used to facilitate the placement of venous stents. It is primarily used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K031211 ↗
Decision Date
July 17, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Prevail Steerable Catheter Set, manufactured by Medtronic Vascular, was cleared by the FDA under 510k pathway K031211 on July 17, 2003. It is a Class 2 medical device.
What It Is
The Attain Prevail Steerable Catheter Set is designed to assist in the precise placement of venous stents. It features a steerable mechanism that allows for enhanced maneuverability within the venous system. This device is particularly useful in navigating complex vascular anatomies, providing clinicians with improved control during procedures.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, particularly in patients with venous obstructions or insufficiencies. It is utilized in interventional cardiology and vascular surgery settings, often in hospital catheterization labs. The patient population includes those with conditions such as chronic venous insufficiency or post-thrombotic syndrome.
Indications for Use
The FDA indications for the Attain Prevail Steerable Catheter Set include its use in facilitating the placement of venous stents. It is intended for patients who require stenting due to venous blockages or structural abnormalities.
Practical Considerations
The catheter set typically comes in various sizes to accommodate different patient anatomies. It is compatible with standard venous stents and guidewires. Clinicians should be familiar with steerable catheter techniques to maximize the device's effectiveness.
Frequently Asked Questions
What is the Attain Prevail Steerable Catheter Set used for?
It is used to facilitate the placement of venous stents in patients with venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of venous stents in patients with venous blockages or structural abnormalities.
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.