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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 aspiration catheters, primarily used in neurovascular procedures. Key evidence highlights its high success rates in navigating tortuous arteries.
FDA Clearance Information
Pathway
510K
Number
K182512 ↗
Decision Date
December 10, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Route 92 Medical Delivery Catheter was cleared by the FDA via the 510(k) pathway on December 10, 2018. It is manufactured by Route 92 Medical and classified as a Class 2 device.
What It Is
The device is a delivery catheter used for intracranial navigation of large bore aspiration catheters. It features a soft, flexible, tapered tip to facilitate smooth passage through tortuous neurovascular pathways, minimizing resistance.
Clinical Applications
Commonly used in neurovascular procedures, the catheter aids in the delivery of therapeutic devices during aspiration mechanical thrombectomy for acute ischemic strokes. It is particularly useful in navigating complex arterial structures.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, conducted between 2025 and 2026. These studies evaluate the device's performance in various clinical settings.
Reported Outcomes
Published studies report high success rates in the intracranial delivery of aspiration catheters with the Route 92 Medical Delivery Catheter. The device demonstrates efficacy in minimizing complications during thrombectomy procedures for acute ischemic strokes.
Safety Profile
Reported complications include minimal adverse events related to device navigation through tortuous arteries. The studies highlight the catheter's safety profile in clinical use.
Evidence Limitations
Current evidence is limited by the short duration of follow-up and the need for larger sample sizes to validate findings. Further research is needed to explore long-term outcomes and broader clinical applications.
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 delivering aspiration catheters during thrombectomy in acute ischemic stroke cases.
What outcomes have been reported in clinical studies?
Studies report high success rates in catheter delivery and effective thrombectomy outcomes with minimal complications.
What complications have been reported?
Safety data indicate minimal complications, primarily related to device navigation through complex arterial structures.
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.