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reflex ballon guide catheter
Reverse Medical
Summary: The Reflex Balloon Guide Catheter is a medical device used to assist in the placement of stents within venous systems. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K112262 ↗
Decision Date
November 2, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Reflex Balloon Guide Catheter by Reverse Medical was cleared through the FDA 510(k) pathway on November 2, 2011. It is classified as a Class 2 device under product code DQY.
What It Is
The Reflex Balloon Guide Catheter is a specialized catheter designed to facilitate the delivery and placement of stents in venous systems. It features a balloon mechanism that can be inflated to stabilize the catheter during procedures, ensuring precise placement and reducing the risk of stent migration. This device is particularly useful in complex vascular interventions where stability and control are paramount.
Clinical Applications
This device is commonly used in endovascular procedures involving the placement of venous stents, such as in the treatment of venous obstructions or insufficiencies. Interventional radiologists and vascular surgeons may use it in hospital settings, particularly in catheterization labs. It is suitable for adult patients with conditions requiring venous stenting, such as chronic venous insufficiency or post-thrombotic syndrome.
Indications for Use
The FDA indications for the Reflex Balloon Guide Catheter include its use in procedures requiring the placement of stents in venous systems. It is intended for patients who need venous support due to blockages or other vascular conditions.
Practical Considerations
The Reflex Balloon Guide Catheter comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and stent delivery systems. Clinicians should be familiar with balloon inflation techniques to ensure optimal device performance and patient safety.
Frequently Asked Questions
What is the Reflex Balloon Guide Catheter used for?
It is used to assist in the placement of stents within venous systems, providing stability and control during endovascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of stents in venous systems, addressing conditions like venous obstructions.
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.