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route 92 medical access system
Route 92 Medical
Summary: The Route 92 Medical Access System is a venous stent device used primarily for vascular access. Key evidence highlights its role in mechanical thrombectomy for large vessel occlusions.
FDA Clearance Information
Pathway
510K
Number
K180201 ↗
Decision Date
May 23, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Route 92 Medical Access System was cleared by the FDA via the 510(k) pathway on May 23, 2018. It is manufactured by Route 92 Medical and classified as a Class 2 device.
What It Is
The Route 92 Medical Access System is a venous stent designed to facilitate vascular access. It is used in endovascular procedures, particularly for mechanical thrombectomy in stroke management.
Clinical Applications
Commonly used in scenarios requiring vascular access for mechanical thrombectomy, particularly in cases of large vessel occlusions. It is integral in acute ischemic stroke interventions.
Evidence Summary
The literature includes 10 peer-reviewed studies, comprising RCTs, prospective, and retrospective analyses. The studies span from 2025, focusing on clinical outcomes and safety in thrombectomy procedures.
Reported Outcomes
Published studies report that the Route 92 Medical Access System is effective in achieving recanalization in mechanical thrombectomy procedures. It has shown potential for improved first pass success and faster recanalization in large vessel occlusions.
Safety Profile
Reported complications include potential risks associated with vascular access and thrombectomy procedures. However, specific adverse events related to the device itself are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of large-scale, long-term studies specifically evaluating the Route 92 Medical Access System. Further research is needed to fully understand its safety profile and efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Route 92 Medical Access System?
The device is indicated for use in vascular access during mechanical thrombectomy procedures, particularly for large vessel occlusions in acute ischemic stroke.
What outcomes have been reported in clinical studies?
Studies have reported effective recanalization and potential for improved first pass success in mechanical thrombectomy procedures.
What complications have been reported?
Safety data indicate potential complications related to vascular access and thrombectomy, though specific device-related adverse events are not detailed.
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.