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spex lp support catheter
Reflow Medical
Summary: The Spex LP Support Catheter is a medical device used in vascular procedures, primarily by interventional radiologists and cardiologists. It assists in the placement and support of guidewires and other devices within the vascular system.
FDA Clearance Information
Pathway
510K
Number
K200094 ↗
Decision Date
March 18, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Spex LP Support Catheter was cleared through the FDA's 510(k) pathway on March 18, 2020. Manufactured by Reflow Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Spex LP Support Catheter is a specialized catheter designed to provide support and facilitate the delivery of guidewires and other interventional devices within the vascular system. It is constructed to navigate through complex vascular anatomy, offering flexibility and support. This device is particularly useful in procedures requiring precise navigation and positioning within blood vessels.
Clinical Applications
Commonly used in endovascular procedures, the Spex LP Support Catheter is employed in settings such as hospitals and specialized clinics. It is utilized by interventional radiologists and cardiologists during procedures like angioplasty or stent placement. This device is especially beneficial in treating patients with peripheral artery disease or other vascular conditions requiring precise device placement.
Indications for Use
The FDA indications for the Spex LP Support Catheter include its use in vascular procedures to support the placement of guidewires and other devices. It is intended for patients requiring vascular interventions, such as those with narrowed or blocked blood vessels.
Practical Considerations
The Spex LP Support Catheter comes in various sizes to accommodate different vascular anatomies. It is compatible with standard guidewires and interventional devices. Clinicians should be familiar with catheter handling and navigation techniques to maximize its effectiveness.
Frequently Asked Questions
What is Spex LP Support Catheter used for?
It is used to support the placement of guidewires and other devices during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular procedures to support the placement of guidewires and other interventional devices.
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.