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Route 92 Medical Delivery Catheter
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 ?
510(k)
Number ?
K182512 ↗
Decision Date ?
December 10, 2018
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous intravascular access and delivery of compatible catheters or devices.
- Use in blood vessels during diagnostic or interventional procedures under appropriate imaging guidance.
Clinical Applications
- Delivery and positioning of compatible intravascular catheters.
- Percutaneous catheter-based vascular procedures.
- Navigation through selected blood vessels under fluoroscopic or other appropriate imaging guidance.
Reported off-label uses
- Delivery of large-bore aspiration catheters during mechanical thrombectomy for acute ischemic stroke, when consistent with the catheter's compatibility and the treating physician's judgment.
- Supportive access during other complex neurovascular interventions.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- Confirm the catheter's available French sizes, working length, inner diameter, and compatibility with the intended catheter or device before use.
- Use fluoroscopy or other appropriate imaging to monitor advancement and positioning; tortuous or diseased vessels may increase the risk of spasm, dissection, perforation, or thrombosis.
- Follow the current manufacturer instructions for preparation, flushing, guidewire use, and maximum insertion or pressure limits.
- MRI safety and conditional-use details depend on the exact model and labeling; verify the current instructions for use before an MRI examination.
- Contraindications and warnings include unsuitable vessel anatomy, inability to obtain safe vascular access, and known contraindications to the planned procedure, anticoagulation, contrast, or anesthesia.
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.