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6f wallaby long sheath
Wallaby Medical
Summary: The 6f Wallaby Long Sheath is a medical device used primarily in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to facilitate the placement of stents in veins.
FDA Clearance Information
Pathway
510K
Number
K222603 ↗
Decision Date
March 2, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 6f Wallaby Long Sheath, manufactured by Wallaby Medical, received FDA clearance via the 510(k) pathway on March 2, 2023. It is classified as a Class 2 device under product code DQY.
What It Is
The 6f Wallaby Long Sheath is a flexible, elongated tube designed to provide access to the venous system for the placement of stents. It is used to navigate through the vascular system, allowing clinicians to deliver stents to targeted areas with precision. The sheath's design facilitates smooth insertion and positioning within the veins, minimizing trauma to the vessel walls.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, particularly in cases of venous obstructions or insufficiencies. Interventional radiologists and vascular surgeons often employ it in hospital settings, especially in catheterization labs. It is suitable for adult patients who require venous stenting due to conditions such as deep vein thrombosis or chronic venous insufficiency.
Indications for Use
The FDA-cleared indications for the 6f Wallaby Long Sheath involve its use in facilitating the delivery of stents within the venous system. It is intended for patients with conditions that necessitate venous stenting to restore proper blood flow.
Practical Considerations
The 6f Wallaby Long Sheath is typically compatible with a range of stent sizes and is designed for ease of use during venous access procedures. Clinicians should be familiar with the specific technique for sheath insertion and stent deployment to optimize outcomes.
Frequently Asked Questions
What is the 6f Wallaby Long Sheath 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 radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in delivering stents within the venous system to treat conditions like 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.