📋 FDA Reference
Silk Road Acccess Catheter
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 ?
510(k)
Number ?
K143459 ↗
Decision Date ?
April 1, 2015
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Provides percutaneous access to blood vessels for diagnostic or therapeutic vascular procedures.
- Is intended to facilitate introduction, placement, or exchange of guidewires and other compatible intravascular devices.
- Use must follow the device-specific FDA-cleared labeling, including its stated vessel access route, size, and compatibility requirements.
Clinical Applications
- Obtaining percutaneous vascular access before an endovascular intervention.
- Providing a conduit for guidewires or other compatible devices during catheter-based treatment.
- Facilitating vascular procedures in which an access catheter is needed to reach the target vessel.
Practical Considerations
- The available FDA summary does not list specific catheter sizes, lengths, access routes, or compatible devices; clinicians should consult the current manufacturer instructions for use.
- Use requires standard sterile vascular-access technique and imaging guidance appropriate to the procedure, such as fluoroscopy or ultrasound.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, dissection, and perforation.
- MRI safety depends on the exact catheter model and whether it is being used with other implanted or retained devices; verify the current labeling before MRI.
- Do not use if the device packaging is damaged, expired, or otherwise inconsistent with the manufacturer instructions. Patient-specific contraindications depend on the planned access route and procedure.
Procedures that use this device
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.