đź“‹ FDA Reference
spex support catheter
Reflow Medical
Summary: The Spex Support Catheter by Reflow Medical is a Class 2 device used in vascular procedures to assist in the placement of guidewires and other devices. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K173662 ↗
Decision Date
December 20, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Spex Support Catheter was cleared through the FDA 510k pathway on December 20, 2017. 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 placement and support of guidewires and other interventional devices during vascular procedures. It is constructed to provide flexibility and support, allowing for navigation through tortuous vascular pathways. This device is particularly useful in complex vascular interventions where precise device placement is critical.
Clinical Applications
Commonly used in endovascular procedures, the Spex Support Catheter is utilized in settings such as interventional radiology and vascular surgery. It is often employed in procedures involving the placement of venous stents, particularly in patients with peripheral vascular disease or other conditions requiring vascular access. The catheter aids in navigating challenging vascular anatomy, making it a valuable tool in both elective and emergency interventions.
Indications for Use
The FDA-cleared indications for the Spex Support Catheter include its use in assisting the placement of guidewires and other devices in vascular procedures. It is indicated for patients requiring vascular access or intervention, such as those needing venous stenting.
Practical Considerations
The Spex Support Catheter is available in various sizes to accommodate different vascular anatomies. It is compatible with standard guidewires and other interventional devices. Clinicians should be familiar with the catheter's handling characteristics and ensure proper technique to optimize outcomes.
Frequently Asked Questions
What is the Spex Support Catheter used for?
The Spex Support Catheter is used to assist in the placement of guidewires and other interventional devices during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Spex Support Catheter in their procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include assisting in the placement of guidewires and devices in vascular procedures, particularly for 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.