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percutaneous introd w sideport three-way stopcock
Daig
Summary: The percutaneous introducer with sideport and three-way stopcock by Daig is a medical device used primarily in vascular procedures for accessing blood vessels. It is typically utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K910861 ↗
Decision Date
May 7, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on May 7, 1991. Manufactured by Daig, it is classified as a Class 2 medical device under product code DYB.
What It Is
The percutaneous introducer with sideport is a medical device designed to facilitate vascular access. It includes a three-way stopcock, allowing for the administration of fluids or medications and the withdrawal of blood samples. This device is essential in procedures requiring precise vascular access, providing a stable and secure entry point into the vessel.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is integral to procedures such as angiography, embolization, and catheter-based interventions. It is used in hospital settings, particularly in catheterization labs and interventional suites, and is suitable for adult and pediatric patients requiring vascular access.
Indications for Use
The device is indicated for use in procedures requiring vascular access, such as the introduction of catheters or other instruments into the vascular system. It is suitable for patients needing diagnostic or therapeutic vascular interventions.
Practical Considerations
When using this device, clinicians should consider the appropriate size for the patient's vessel to ensure compatibility with other instruments. The sideport allows for simultaneous fluid administration and pressure monitoring, enhancing procedural efficiency.
Frequently Asked Questions
What is the percutaneous introducer with sideport used for?
It is used for vascular access in procedures like angiography and catheter-based interventions.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as catheter introduction into the vascular system.
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.