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route 92 medical delivery catheter
Route 92 Medical
Summary: The Route 92 Medical Delivery Catheter is designed for intracranial delivery of large bore aspiration catheters, primarily used in neurovascular procedures. Key evidence highlights its high success rates and minimal complications in thrombectomy for acute ischemic strokes.
FDA Clearance Information
Pathway
510K
Number
K190431 ↗
Decision Date
March 21, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Route 92 Medical Delivery Catheter was cleared via the FDA 510(k) pathway on March 21, 2019. 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 Delivery Catheter is a neurovascular device designed to facilitate the delivery of large bore aspiration catheters into intracranial vessels. It features a soft, flexible, tapered tip to navigate tortuous arterial pathways, reducing resistance and the 'ledge effect'.
Clinical Applications
Commonly used in mechanical thrombectomy procedures for acute ischemic stroke, the Route 92 Medical Delivery Catheter aids in the delivery of therapeutic devices through complex neurovascular anatomy. It is particularly useful in cases involving tortuous internal carotid arteries.
Evidence Summary
The available literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, published between 2025 and 2026. These studies focus on the catheter's performance in neurovascular procedures, particularly in stroke interventions.
Reported Outcomes
Published studies report high success rates in the intracranial delivery of aspiration catheters using the Route 92 Medical Delivery Catheter. The device has demonstrated efficacy in improving navigation through tortuous vessels and achieving successful thrombectomy in acute ischemic stroke cases.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a low incidence of device-related complications. The catheter's design helps mitigate risks associated with navigating complex vascular anatomy.
Evidence Limitations
Current evidence is limited by the relatively short follow-up periods and the need for larger, multicenter trials to validate findings. Further research is needed to explore long-term outcomes and compare efficacy with alternative devices.
Frequently Asked Questions
What are the clinical indications for Route 92 Medical Delivery Catheter?
The catheter is indicated for use in neurovascular procedures, particularly for the delivery of large bore aspiration catheters in mechanical thrombectomy for acute ischemic stroke.
What outcomes have been reported in clinical studies?
Studies have reported high success rates in catheter delivery and effective thrombectomy outcomes with minimal complications.
What complications have been reported?
Safety data indicate minimal complications, with the catheter's design reducing the risk of adverse events during navigation through tortuous vessels.
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.