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percutaneous introducer tray
Thomas Medical Products
Summary: The percutaneous introducer tray is a medical device used to facilitate the insertion of catheters or other medical instruments into the vascular system. It is primarily used by interventional radiologists, cardiologists, and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K904608 ↗
Decision Date
December 3, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on December 3, 1990. Manufactured by Thomas Medical Products, it is classified as a Class 2 device under product code DQY.
What It Is
The percutaneous introducer tray is a sterile, single-use kit that includes components necessary for accessing the vascular system. It typically contains a sheath, dilator, and guidewire, which work together to provide a conduit for the insertion of catheters or other devices into blood vessels. This device is essential in procedures requiring vascular access, ensuring safety and efficiency.
Clinical Applications
This device is commonly used in procedures such as central venous catheter placement, angiography, and the deployment of venous stents. It is frequently utilized in hospital settings, particularly in interventional radiology suites, cardiac catheterization labs, and operating rooms. The patient population includes those requiring vascular access for diagnostic or therapeutic interventions.
Indications for Use
The percutaneous introducer tray is indicated for use in patients needing vascular access for procedures like catheter insertion. It is suitable for a wide range of conditions where venous access is necessary, such as in the administration of medications, fluids, or for diagnostic imaging.
Practical Considerations
The introducer tray comes in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with a range of catheters and guidewires. Clinicians should be familiar with the technique of percutaneous access and the specific components of the tray to ensure optimal outcomes.
Frequently Asked Questions
What is the percutaneous introducer tray used for?
It is used to facilitate the insertion of catheters or other medical instruments into the vascular system.
What specialties typically use this device?
Interventional radiologists, cardiologists, and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring vascular access for procedures such as catheter insertion and 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.