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percutaneous introducer seldinger style
Dip
Summary: The percutaneous introducer seldinger style 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.
FDA Clearance Information
Pathway
510K
Number
K813019 ↗
Decision Date
November 16, 1981
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on November 16, 1981, by the manufacturer Dip. It is classified as a Class 2 device under product code DYB.
What It Is
The percutaneous introducer seldinger style is a device designed to aid in the insertion of catheters into blood vessels. It utilizes the Seldinger technique, which involves puncturing the vessel with a needle, inserting a guidewire, and then advancing the introducer over the wire. This method minimizes trauma to the vessel and allows for precise placement of catheters.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and catheter-based interventions. It is used in settings like hospitals and specialized clinics, primarily for adult patients requiring vascular access for diagnostic or therapeutic purposes.
Indications for Use
The percutaneous introducer is indicated for use in procedures requiring vascular access, such as the insertion of catheters for diagnostic imaging or therapeutic interventions. It is suitable for patients needing precise and minimally invasive vascular access.
Practical Considerations
The device typically comes in various sizes to accommodate different vessel diameters and catheter types. It is important to select the appropriate size for the patient's anatomy and the specific procedure. Compatibility with other vascular instruments should be verified before use.
Frequently Asked Questions
What is percutaneous introducer seldinger style used for?
It is used to facilitate the insertion of catheters into blood vessels for diagnostic or therapeutic procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as catheter insertion for imaging or treatment.
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.