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reverse medical reflex guide catheter
Reverse Medical
Summary: The Reverse Medical Reflex Guide Catheter is a device used to facilitate the delivery of interventional devices in venous procedures. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K110055 ↗
Decision Date
April 5, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Reverse Medical Reflex Guide Catheter was cleared through the FDA 510(k) pathway on April 5, 2011. Manufactured by Reverse Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Reverse Medical Reflex Guide Catheter is a flexible tube designed to provide a pathway for other medical devices during venous interventions. It is engineered to navigate the vascular system with precision, allowing for the delivery of stents and other therapeutic devices. Its design includes features that enhance stability and control during procedures.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, particularly in cases of venous obstructions or insufficiencies. Interventional radiologists and vascular surgeons utilize it in hospital settings, often in patients with conditions such as deep vein thrombosis or chronic venous insufficiency. It is particularly useful in complex cases requiring precise device placement.
Indications for Use
The FDA-cleared indications for this device include facilitating the placement of interventional devices within the venous system. It is intended for patients who require venous stenting due to conditions like blockages or structural abnormalities.
Practical Considerations
The Reverse Medical Reflex Guide Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of interventional devices, and clinicians should be familiar with its handling characteristics to optimize procedural outcomes.
Frequently Asked Questions
What is the Reverse Medical Reflex Guide Catheter used for?
It is used to facilitate the delivery of interventional devices, such as stents, within the venous system during procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in venous interventions.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of interventional devices in the venous system, particularly for patients with venous obstructions or insufficiencies.
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.