📋 FDA Reference
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 ?
510(k)
Number ?
K222603 ↗
Decision Date ?
March 2, 2023
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Provides access to the vascular system for the delivery of compatible interventional devices.
- Facilitates catheter or stent delivery during percutaneous endovascular procedures.
- Intended for use by trained healthcare professionals in appropriately selected patients.
Clinical Applications
- Providing access for venous stent delivery.
- Supporting endovascular treatment of venous obstruction when a compatible device is indicated.
- Maintaining a conduit between the vascular access site and the target vessel during catheter-based procedures.
Practical Considerations
- The 6F designation refers to the approximate French size of the sheath; clinicians must confirm the device's working length, inner diameter, and compatibility with the intended catheter or stent.
- Insertion and advancement should be performed under appropriate imaging guidance by clinicians trained in percutaneous vascular access.
- Access-site bleeding, hematoma, vessel injury, infection, thrombosis, embolization, and other catheter-related complications are possible.
- MRI safety and conditional-use information should be confirmed in the current manufacturer instructions for use; do not assume the sheath is MR safe.
- Contraindications and precautions depend on the planned procedure and patient factors, including unsuitable vascular anatomy, active infection at the access site, uncorrected bleeding risk, or inability to tolerate anticoagulation when required.
Procedures that use this device
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.