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silk road access catheter
Silk Road Medical
Summary: The Silk Road Access Catheter is a device used primarily in venous stenting procedures. It was FDA-cleared via the 510k pathway. Key evidence highlights its application in neurovascular interventions.
FDA Clearance Information
Pathway
510K
Number
K130649 ↗
Decision Date
November 1, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Silk Road Access Catheter was cleared by the FDA through the 510k pathway on November 1, 2013. It is manufactured by Silk Road Medical and classified as a Class 2 device.
What It Is
The Silk Road Access Catheter is designed for use in venous stenting procedures. It facilitates access to the vascular system, allowing for interventions such as neurovascular procedures.
Clinical Applications
Commonly used in neurovascular interventions, the Silk Road Access Catheter aids in procedures requiring vascular access, such as carotid artery stenting and other endovascular treatments.
Evidence Summary
The available literature includes 10 studies, comprising various types such as RCTs and case series, published between 2023 and 2025. These studies explore the catheter's use in different clinical settings.
Reported Outcomes
Published studies report the Silk Road Access Catheter's effectiveness in facilitating neurovascular interventions. Outcomes include successful access and intervention in carotid atherosclerotic disease and other vascular conditions.
Safety Profile
Reported complications include potential risks associated with vascular access, such as bleeding or vessel injury. However, specific safety data from the studies are limited.
Evidence Limitations
Evidence gaps include a lack of large-scale RCTs specifically focused on the Silk Road Access Catheter. Further research is needed to fully understand long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for Silk Road Access Catheter?
The catheter is indicated for use in venous stenting procedures, particularly in neurovascular interventions and carotid artery stenting.
What outcomes have been reported in clinical studies?
Studies report successful vascular access and intervention in neurovascular procedures, with positive outcomes in managing carotid atherosclerotic disease.
What complications have been reported?
Safety data indicate potential complications such as bleeding or vessel injury, though specific adverse events are not extensively detailed in the studies.
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.