📊 Evidence-Based Reference
Route 92 Medical Delivery Catheter
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 ?
510(k)
Number ?
K190431 ↗
Decision Date ?
March 21, 2019
Product Code ?
DQY Catheter, Percutaneous
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'.
FDA-Cleared Indications
- For the introduction of compatible interventional devices into the peripheral, coronary and neuro vasculature.
- For use in the vascular system in conjunction with compatible guidewires and interventional devices.
Clinical Applications
- Delivery of compatible large-bore aspiration catheters during neurovascular procedures.
- Endovascular access to intracranial vessels during mechanical thrombectomy for acute ischemic stroke.
- Navigation through tortuous arterial anatomy, including the internal carotid artery, to support delivery of another interventional device.
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.
Practical Considerations
- The catheter must be used with compatible guidewires, aspiration catheters and other interventional devices according to the current manufacturer instructions for use.
- It is advanced over a guidewire under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- The flexible, tapered distal tip is designed to reduce resistance during navigation, but vessel injury, dissection, perforation, vasospasm, thrombosis and embolization remain possible risks.
- Available sizes, usable length, inner and outer diameters, and compatibility depend on the specific model and should be confirmed in the current product documentation.
- MRI safety and conditions should be verified in the current labeling for the exact catheter model; do not assume MRI compatibility from the device name alone.
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.