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burron percutaneous inducer set
Burron Medical Products
Summary: The Burron Percutaneous Inducer Set is a medical device used primarily for venous access in procedures involving venous stents. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K810460 ↗
Decision Date
March 11, 1981
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Burron Percutaneous Inducer Set was cleared via the FDA 510(k) pathway on March 11, 1981. It is manufactured by Burron Medical Products and classified as a Class 2 device under product code DQY.
What It Is
The Burron Percutaneous Inducer Set is designed to facilitate the insertion of venous stents. It typically includes components such as a sheath and dilator to aid in accessing the venous system percutaneously. This device is essential in procedures requiring precise placement of stents to maintain venous patency.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for patients requiring venous stenting due to conditions like venous insufficiency or obstruction. It is used in both inpatient and outpatient settings, often in patients with chronic venous diseases or those undergoing complex vascular procedures.
Indications for Use
The device is indicated for use in patients who require venous stenting, often due to conditions such as deep vein thrombosis or chronic venous insufficiency. It helps in maintaining open venous channels, improving blood flow.
Practical Considerations
The Burron Percutaneous Inducer Set is available in various sizes to accommodate different patient anatomies and procedural requirements. Clinicians should ensure compatibility with other interventional tools and be familiar with percutaneous techniques to optimize outcomes.
Frequently Asked Questions
What is the Burron Percutaneous Inducer Set used for?
It is used for facilitating the insertion of venous stents in procedures requiring venous access.
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 requiring venous stenting, often due to venous insufficiency or obstruction.
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.