đź“‹ FDA Reference
route 92 medical sheath system
Route 92 Medical
Summary: The Route 92 Medical Sheath System is a Class 2 medical device used in neurointerventional procedures, particularly for accessing venous stents. It is typically used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K191717 ↗
Decision Date
January 13, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Route 92 Medical Sheath System was cleared through the FDA 510(k) pathway on January 13, 2020. It is manufactured by Route 92 Medical and classified as a Class 2 device under product code DQY.
What It Is
The Route 92 Medical Sheath System is a medical device designed to provide vascular access during neurointerventional procedures. It is particularly useful in cases where traditional transfemoral access is challenging, offering alternative routes such as transradial or transbrachial access. This system aids in the placement of venous stents, facilitating the treatment of various vascular conditions.
Clinical Applications
This device is commonly used in neurointerventional procedures, especially when traditional access routes are not viable due to anatomical challenges. It is utilized in settings such as hospitals and specialized clinics by interventional radiologists and neurosurgeons. Patient populations include those with complex vascular anatomies or conditions requiring venous stenting.
Indications for Use
The FDA indications suggest that this device is intended for patients requiring venous stenting, particularly when standard access routes are not feasible. It is suitable for conditions involving complex vascular anatomies.
Practical Considerations
The Route 92 Medical Sheath System is compatible with various stent sizes, offering flexibility in procedural planning. Clinicians should consider patient-specific anatomical factors when selecting access routes, and training in alternative access techniques may be beneficial.
Related Literature
The linked study explored the feasibility of using transradial or transbrachial approaches in neurointerventional procedures. It found these alternative access routes to be viable options in cases where transfemoral access is difficult. However, the study was limited to a single medical center's experience, suggesting the need for broader research to confirm these findings.
Frequently Asked Questions
What is the Route 92 Medical Sheath System used for?
It is used for providing vascular access in neurointerventional procedures, particularly for venous stenting.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures, especially when traditional access routes are not suitable.
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.