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attain clarity 6225 venogram balloon catheter
Medtronic
Summary: The Attain Clarity 6225 Venogram Balloon Catheter is a medical device used for venous procedures, particularly in the placement of venous stents. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K121219 ↗
Decision Date
September 25, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Clarity 6225 Venogram Balloon Catheter was cleared through the FDA 510k pathway on September 25, 2012. It is manufactured by Medtronic and classified as a Class 2 device.
What It Is
The Attain Clarity 6225 Venogram Balloon Catheter is designed to assist in venous procedures by providing a means to visualize and access veins. It works by inflating a balloon within the vein to help with the placement of stents or to assess venous anatomy. This device is particularly useful in procedures requiring precise venous mapping and intervention.
Clinical Applications
This catheter is commonly used in interventional radiology and cardiology settings for procedures involving venous stenting. It is particularly beneficial in patients with complex venous anatomy or those requiring detailed venous mapping prior to stent placement. The device is used in hospital settings, often in catheterization labs or interventional suites.
Indications for Use
The FDA-cleared indications for this device include use in procedures that require venous visualization and stenting. It is intended for patients needing venous interventions, such as those with venous obstructions or anomalies.
Practical Considerations
The Attain Clarity 6225 is available in various sizes to accommodate different venous anatomies. It is compatible with standard guidewires and catheters used in venous procedures. Clinicians should be familiar with balloon inflation techniques and ensure compatibility with other procedural equipment.
Frequently Asked Questions
What is the Attain Clarity 6225 Venogram Balloon Catheter used for?
It is used for venous visualization and stenting procedures, aiding in the placement of venous stents and mapping venous anatomy.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous visualization and stenting, particularly in patients with venous obstructions or anomalies.
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.