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percutaneous catheter introducer adapter
Norton Performance Plastics
Summary: The percutaneous catheter introducer adapter is a medical device used to facilitate the insertion of catheters into blood vessels. It is commonly used by interventional radiologists and cardiologists in procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K800621 ↗
Decision Date
April 24, 1980
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous catheter introducer adapter by Norton Performance Plastics was cleared through the FDA 510(k) pathway on April 24, 1980. It is a Class 2 device under product code DYB.
What It Is
The percutaneous catheter introducer adapter is a device designed to assist in the insertion of catheters into the vascular system. It typically consists of a sheath and a dilator, allowing for smooth and controlled entry into blood vessels. This device is crucial in procedures where vascular access is needed, minimizing trauma to the vessel and reducing the risk of complications.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and catheter-based interventions. It is essential in settings where precise vascular access is required, such as in the treatment of vascular diseases or during diagnostic imaging. The device is suitable for a wide range of patient populations, including those undergoing minimally invasive procedures.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring vascular access, particularly in the insertion of catheters into blood vessels. It is suitable for patients needing diagnostic or therapeutic interventions involving the vascular system.
Practical Considerations
The introducer adapter typically comes in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with standard catheterization equipment, and clinicians should be familiar with the insertion technique to ensure safe and effective use.
Frequently Asked Questions
What is the percutaneous catheter introducer adapter used for?
It is used to facilitate the insertion of catheters into blood vessels, commonly in procedures requiring vascular access.
What specialties typically use this device?
Interventional radiologists and cardiologists frequently use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, particularly for the insertion of catheters into blood vessels.
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.