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6f mach 1 model 34356-xxx
Boston Scientific
Summary: The 6f Mach 1 Model 34356-xxx is a venous stent used to support blood vessels in patients with venous insufficiencies. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K010874 ↗
Decision Date
June 21, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 6f Mach 1 Model 34356-xxx received FDA clearance via the 510(k) pathway on June 21, 2001. Manufactured by Boston Scientific, it is classified as a Class II device under product code DQY.
What It Is
The 6f Mach 1 Model 34356-xxx is a venous stent designed to provide structural support to veins that have become narrowed or obstructed. It is typically made from biocompatible materials that allow it to be safely implanted within the vascular system. The stent is delivered to the target site using a catheter-based system, where it is then expanded to fit the vessel's diameter, helping to restore proper blood flow.
Clinical Applications
This device is commonly used in procedures addressing venous insufficiencies, such as in cases of deep vein thrombosis or chronic venous occlusions. It is primarily used in hospital settings by interventional radiologists and vascular surgeons. The stent is suitable for adult patients who require long-term venous support to alleviate symptoms like swelling and pain associated with poor venous circulation.
Indications for Use
The FDA indications suggest that this device is used for patients with conditions that lead to narrowed or blocked veins. It is particularly useful in treating venous insufficiencies where maintaining open blood vessels is critical for patient health.
Practical Considerations
The 6f Mach 1 Model 34356-xxx is available in various sizes to accommodate different vessel diameters. It is important to ensure compatibility with the patient's anatomy and the delivery system. Proper technique during deployment is crucial to ensure optimal placement and function.
Related Literature
The linked study focuses on measuring plasma parameters during the explosion of a copper foil transducer, using advanced imaging techniques. Although not directly related to the stent, the study highlights the importance of precise measurement techniques in medical device performance. Key findings include the ability to capture shock wave propagation and plasma characteristics, though its direct application to venous stents is limited.
Frequently Asked Questions
What is 6f Mach 1 Model 34356-xxx used for?
It is used to support and maintain open blood vessels in patients with venous insufficiencies.
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 patients with narrowed or obstructed veins, particularly in cases of venous insufficiency.
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.