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spex support catheter
Reflow Medical
Summary: The Spex Support Catheter is a medical device used in vascular procedures, primarily by interventional radiologists and cardiologists. It facilitates the placement and support of guidewires in venous interventions.
FDA Clearance Information
Pathway
510K
Number
K141649 ↗
Decision Date
November 5, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Spex Support Catheter, manufactured by Reflow Medical, was cleared through the FDA 510(k) pathway on November 5, 2014. It is a Class 2 device under product code DQY.
What It Is
The Spex Support Catheter is a flexible, tube-like device designed to assist in the navigation and support of guidewires during vascular procedures. It is used to access and maintain the position within blood vessels, particularly in complex or tortuous anatomy. The catheter's design allows for enhanced maneuverability and support, aiding clinicians in performing precise interventions.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings, particularly in procedures involving venous stenting. It is suitable for use in patients requiring vascular access for diagnostic or therapeutic interventions. The catheter is often employed in hospitals and specialized clinics where vascular procedures are performed, catering to adult and sometimes pediatric populations with vascular conditions.
Indications for Use
The FDA indications for the Spex Support Catheter include its use in facilitating the placement and support of guidewires during vascular interventions. It is intended for patients requiring venous access, particularly in cases where stenting is necessary.
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 can be used with other vascular intervention devices. Clinicians should consider the patient's anatomy and the specific procedural requirements when selecting the appropriate catheter size.
Frequently Asked Questions
What is the Spex Support Catheter used for?
The Spex Support Catheter is used to facilitate the placement and support of guidewires during vascular interventions, particularly in venous stenting procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the Spex Support Catheter in vascular procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include facilitating the placement and support of guidewires during vascular interventions, especially in venous stenting.
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.