đź“‹ FDA Reference
Reverse Medical Reflex Guide Catheter
Product: NavienTM — all models and sizes
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 ?
510(k)
Number ?
K110055 ↗
Decision Date ?
April 5, 2011
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Facilitation of the placement of interventional devices within the venous system.
Clinical Applications
- Providing a pathway for delivery of venous stents.
- Supporting image-guided treatment of venous obstructions when an interventional device must be advanced through the venous system.
- Providing catheter access and support during venous interventions performed by qualified clinicians.
Practical Considerations
- The catheter is available in different sizes and configurations; selection depends on the target vessel, access route, anatomy and device being delivered.
- Compatibility with guidewires, stents and other interventional devices must be confirmed in the current manufacturer instructions for use.
- The catheter is typically advanced under fluoroscopic or other appropriate imaging guidance, often through venous access in the groin, neck or another suitable site.
- MRI safety depends on the specific catheter model and whether it remains in the patient; consult the product labeling before MRI.
- Risks and contraindications include access-site bleeding, vessel injury, infection, thrombosis, embolization and inability to advance or remove the catheter. Patient-specific contraindications and precautions are determined by the treating clinician.
Procedures that use this device
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.