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silk road acccess catheter
Silk Road Medical
Summary: The Silk Road Access Catheter is a medical device used primarily in vascular procedures to facilitate access to venous systems. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K143459 ↗
Decision Date
April 1, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Silk Road Access Catheter was cleared through the FDA 510(k) pathway on April 1, 2015. Manufactured by Silk Road Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Silk Road Access Catheter is a specialized catheter designed to provide access to the venous system, often used in procedures involving venous stents. It features a flexible design to navigate the vascular anatomy and is typically used to facilitate the placement of other devices or treatments within the venous system.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures requiring venous access, such as the placement of venous stents or other interventions to treat venous obstructions. The device is suitable for adult patients with conditions affecting the venous system.
Indications for Use
The Silk Road Access Catheter is indicated for use in providing access to the venous system, particularly in patients requiring interventions such as stenting to address venous blockages or other vascular conditions.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and other vascular devices. Clinicians should be familiar with vascular access techniques to ensure proper use.
Frequently Asked Questions
What is the Silk Road Access Catheter used for?
It is used to provide access to the venous system for procedures such as venous stenting.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for providing venous access in patients requiring interventions like venous stenting.
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.