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spex support catheter
Reflow Medical
Summary: The Spex Support Catheter by Reflow Medical is used in vascular procedures to assist in the delivery of therapeutic devices. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K193012 ↗
Decision Date
February 19, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Spex Support Catheter was cleared via the FDA 510k pathway on February 19, 2020. Manufactured by Reflow Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Spex Support Catheter is a medical device designed to facilitate the delivery of other therapeutic devices during vascular interventions. It is a flexible, tube-like device that helps navigate through blood vessels, providing support and stability. This catheter is particularly useful in complex vascular procedures where precision and control are essential.
Clinical Applications
Commonly used in endovascular procedures, the Spex Support Catheter is employed in settings such as hospitals and specialized vascular centers. It is often utilized by interventional radiologists and vascular surgeons during procedures involving venous stents, particularly in patients with peripheral artery disease or other vascular conditions. The catheter aids in crossing lesions and delivering stents or other devices to the target site.
Indications for Use
The FDA indications for the Spex Support Catheter involve its use in vascular procedures requiring the placement of venous stents. It is intended for patients with conditions that necessitate endovascular intervention, such as blocked or narrowed blood vessels.
Practical Considerations
The Spex Support Catheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and other interventional devices. Clinicians should be familiar with catheter navigation techniques to optimize its use during procedures.
Frequently Asked Questions
What is the Spex Support Catheter used for?
The Spex Support Catheter is used to assist in the delivery of therapeutic devices during vascular interventions, particularly in procedures involving venous stents.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Spex Support Catheter in endovascular procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include its use in vascular procedures requiring the placement of venous stents.
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.