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percutaneous introducer cournand style
Dip
Summary: The percutaneous introducer cournand style is a medical device used for vascular access, primarily by interventional radiologists and cardiologists. It facilitates the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K812973 ↗
Decision Date
November 16, 1981
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous introducer cournand style, manufactured by Dip, was cleared through the FDA 510(k) pathway on November 16, 1981. It is a Class 2 device with the product code DYB.
What It Is
The percutaneous introducer cournand style is a medical device designed to provide vascular access for the introduction of catheters and other instruments. It typically consists of a sheath and a dilator, allowing for smooth entry into the vascular system. This device is essential in procedures requiring the insertion of embolization coils or other therapeutic devices into the bloodstream.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and catheter-based interventions. It is particularly useful in settings where precise vascular access is required, such as in the treatment of vascular anomalies or during diagnostic imaging. Patients who benefit from this device include those undergoing minimally invasive procedures for vascular conditions.
Indications for Use
The FDA indications suggest this device is intended for use in procedures requiring vascular access, such as the introduction of embolization coils. It is suitable for patients needing minimally invasive interventions in the vascular system.
Practical Considerations
Clinicians should consider the size of the introducer relative to the patient's vascular anatomy to ensure compatibility. The device is typically used in conjunction with imaging guidance to ensure accurate placement. Familiarity with the technique of sheath insertion is essential for optimal outcomes.
Frequently Asked Questions
What is the percutaneous introducer cournand style used for?
It is used for gaining vascular access to introduce catheters and other devices into the bloodstream.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for procedures requiring vascular access, such as the introduction of embolization coils.
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.