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Cordis Shuttle Catheter
Summary: The Cordis Shuttle Catheter is a medical device used for vascular access and intervention, primarily by interventional radiologists and cardiologists. It facilitates the placement of stents and other devices in venous procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K915777 ↗
Decision Date ?
February 11, 1992
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Cordis Shuttle Catheter was cleared via the FDA 510k pathway on February 11, 1992. It is manufactured by Cordis and classified as a Class 2 device under product code DQY.
What It Is
The Cordis Shuttle Catheter is a flexible tube designed for vascular access, allowing clinicians to navigate through blood vessels to deliver therapeutic devices such as stents. Its design facilitates smooth passage through the vascular system, minimizing trauma to vessel walls. This catheter is particularly useful in procedures requiring precise placement of devices in the venous system.
FDA-Cleared Indications
- Percutaneous catheter access to blood vessels during diagnostic or therapeutic procedures.
- Delivery, placement, or exchange of compatible intravascular devices when used according to the applicable device labeling.
Clinical Applications
- Establishing vascular access for endovascular procedures.
- Providing a conduit for compatible guidewires, catheters, stents, or other interventional devices.
- Supporting catheter-based treatment of vascular disease when the selected catheter size and configuration are labeled for that procedure.
Practical Considerations
- Available sizes, lengths, lumen dimensions, and tip configurations vary by model; confirm the exact product labeling before use.
- Use only with compatible guidewires, introducers, therapeutic devices, and contrast media.
- The catheter is manipulated under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- Review the instructions for use for contraindications, warnings, maximum pressure ratings, and recommended access technique.
- MRI safety depends on the specific model and whether the catheter is present during scanning; confirm the current manufacturer labeling before MRI.
Related Literature
The linked study describes a novel stent remodeling technique using the Cordis Shuttle Catheter for coiling ruptured wide-neck cerebral aneurysms. The study highlights the catheter's utility in complex neurovascular procedures, demonstrating its ability to facilitate precise device placement. However, the study is limited by its focus on a single case, necessitating further research to validate these findings across larger patient populations.
Procedures that use this device
Frequently Asked Questions
What is the Cordis Shuttle Catheter used for?
It is used for vascular access and intervention, particularly in placing stents and other devices in venous procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The catheter is indicated for vascular access in procedures requiring the placement of stents and other therapeutic devices in the venous system.
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.