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percutaneous introducer w side port 3 way stopcock
Daig
Summary: The percutaneous introducer with a side port and 3-way stopcock by Daig is used in vascular access procedures. It is primarily utilized by interventional radiologists and cardiologists for introducing catheters into blood vessels.
FDA Clearance Information
Pathway
510K
Number
K870374 ↗
Decision Date
March 18, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on March 18, 1987. Manufactured by Daig, it is classified as a Class 2 medical device under product code DYB.
What It Is
The percutaneous introducer with a side port is a medical device designed to facilitate the insertion of catheters into blood vessels. It features a side port for additional fluid administration or pressure monitoring and a 3-way stopcock for controlling fluid flow. This device is essential in procedures requiring vascular access, providing a stable and secure entry point for further interventions.
Clinical Applications
Commonly used in interventional cardiology and radiology, this device is integral in procedures such as angiography, embolization, and catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs, and is used for patients requiring diagnostic or therapeutic vascular access. The device is critical in managing patients with cardiovascular conditions or those undergoing minimally invasive procedures.
Indications for Use
The FDA indications suggest that this device is used for facilitating vascular access in procedures requiring catheter insertion. It is suitable for patients needing diagnostic or therapeutic interventions involving blood vessels.
Practical Considerations
The introducer is available in various sizes to accommodate different catheter diameters. It is compatible with standard catheterization equipment and requires careful handling to maintain sterility. Clinicians should be familiar with the technique for inserting and securing the introducer to ensure optimal performance.
Frequently Asked Questions
What is the percutaneous introducer with side port used for?
It is used for vascular access to facilitate the insertion of catheters during procedures like angiography and embolization.
What specialties typically use this device?
Interventional cardiologists and radiologists primarily use this device in catheterization labs and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access for catheter insertion, such as diagnostic or therapeutic interventions involving 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.