đź“‹ FDA Reference
long length percutaneous introducer set
Thomas Medical Products
Summary: The long length percutaneous introducer set is a medical device used to facilitate the insertion of catheters or other instruments into the vascular system. It is commonly used by interventional radiologists and cardiologists in procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K924456 ↗
Decision Date
March 22, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on March 22, 1993. Manufactured by Thomas Medical Products, it is classified as a Class 2 device under product code DYB.
What It Is
The long length percutaneous introducer set is designed to provide access to the vascular system, allowing for the introduction of catheters or other devices. It typically includes a sheath, dilator, and guidewire, which work together to facilitate smooth and safe vascular entry. This device is essential in procedures that require precise and stable vascular access, minimizing trauma to the vessel.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, angiography, and the placement of vascular stents or coils. It is particularly useful in settings where long vascular access is required, such as in the treatment of aneurysms or vascular malformations. Patients undergoing these procedures often have complex vascular conditions that necessitate precise device placement.
Indications for Use
The FDA-cleared indications for this device involve facilitating the introduction of catheters or other instruments into the vascular system. It is used in patients who require vascular interventions, such as those with vascular blockages or abnormalities.
Practical Considerations
When using this device, clinicians should consider the appropriate size and length based on the patient's anatomy and the specific procedure. Compatibility with other devices, such as catheters and guidewires, is crucial for successful outcomes. Proper technique in insertion and handling can reduce the risk of complications such as vessel trauma or infection.
Frequently Asked Questions
What is the long length percutaneous introducer set used for?
It is used to facilitate the insertion of catheters or other instruments into the vascular system, commonly in interventional radiology and cardiology procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters or other instruments into the vascular system for patients needing vascular interventions.
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.