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paragon 8f balloon guide catheter
Wallaby Medical
Summary: The Paragon 8F Balloon Guide Catheter by Wallaby Medical is a device used in endovascular procedures to assist with the placement of venous stents. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K232437 ↗
Decision Date
October 13, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Paragon 8F Balloon Guide Catheter was cleared through the FDA 510k pathway on October 13, 2023, by Wallaby Medical. It is classified as a Class 2 medical device.
What It Is
The Paragon 8F Balloon Guide Catheter is a specialized catheter designed to facilitate the delivery and placement of venous stents during endovascular procedures. It features a balloon component that can be inflated to temporarily occlude blood flow, providing a stable environment for stent deployment. This device is crucial in procedures requiring precise stent placement in venous systems.
Clinical Applications
The Paragon 8F Balloon Guide Catheter is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the treatment of venous obstructions or stenosis, such as in the iliac or femoral veins. The device is suitable for adult patients requiring venous stenting, often in a hospital or specialized outpatient setting.
Indications for Use
This device is indicated for use in patients requiring venous stenting, particularly those with venous obstructions or narrowing. It helps in the accurate placement of stents within the venous system, ensuring optimal blood flow restoration.
Practical Considerations
The Paragon 8F Balloon Guide Catheter typically comes in various lengths to accommodate different anatomical requirements. It is compatible with standard guidewires and stent systems. Clinicians should be familiar with balloon inflation techniques and ensure proper sizing to match the patient's venous anatomy.
Frequently Asked Questions
What is the Paragon 8F Balloon Guide Catheter used for?
It is used to assist in the placement of venous stents during endovascular procedures, particularly in cases of venous obstructions.
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 patients requiring venous stenting to treat obstructions or narrowing in the venous system.
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.