📋 FDA Reference
Reflex Ballon Guide Catheter
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 ?
510(k)
Number ?
K112262 ↗
Decision Date ?
November 2, 2011
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- For use in procedures involving the placement of stents in the peripheral venous system.
- Used to support delivery and positioning of venous stents during endovascular treatment.
Clinical Applications
- Guiding and supporting venous stent placement in peripheral veins.
- Providing catheter stability during endovascular treatment of venous obstruction when a venous stent is indicated.
- Temporary balloon occlusion or flow control during a labeled venous stenting procedure, when specified by the device instructions for use.
Practical Considerations
- Available dimensions and balloon specifications must be matched to the target vessel, access route, guidewire, and stent delivery system.
- The balloon should be inflated and deflated only according to the instructions for use, using the recommended inflation medium and pressure limits.
- The operator should confirm compatibility with the intended guidewire, introducer sheath, and venous stent system before the procedure.
- MRI safety depends on the exact device configuration and labeling; the current manufacturer instructions should be reviewed before MRI.
- Potential contraindications and risks include unsuitable vessel size, vessel injury, thrombosis, dissection, perforation, bleeding, embolization, balloon rupture, and device malfunction.
Procedures that use this device
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.