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diag fast-cath duo trio removable hemostasis adapters w sideports 3-way stopcocks
Daig
Summary: The Diag Fast-Cath Duo Trio is a removable hemostasis adapter with sideports and 3-way stopcocks, used in interventional procedures. It is primarily utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K954317 ↗
Decision Date
November 28, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Diag Fast-Cath Duo Trio was cleared via the FDA 510(k) pathway on November 28, 1995. Manufactured by Daig, it is classified as a Class II medical device.
What It Is
The Diag Fast-Cath Duo Trio is a medical device designed to facilitate vascular access and hemostasis during interventional procedures. It includes removable hemostasis adapters with sideports and 3-way stopcocks, allowing for efficient fluid management and catheter manipulation. This device is essential in procedures requiring precise control over blood flow and catheter positioning.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is integral in procedures such as embolization, angiography, and catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs and interventional suites, and is used on patients requiring vascular access for diagnostic or therapeutic purposes.
Indications for Use
The FDA indications suggest its use in procedures involving embolization coils, which are typically employed to treat vascular abnormalities or control bleeding. This device is suited for patients needing precise vascular interventions.
Practical Considerations
The device is available in various sizes to accommodate different catheter diameters and is compatible with standard interventional equipment. Clinicians should ensure proper technique in securing the adapter to maintain hemostasis and prevent complications.
Frequently Asked Questions
What is Diag Fast-Cath Duo Trio used for?
It is used to facilitate vascular access and hemostasis in interventional procedures, such as embolization and angiography.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures involving embolization coils, aiding in vascular access and hemostasis.
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.