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fast-cath hemostasis introducer
Daig
Summary: The Fast-Cath Hemostasis Introducer by Daig is a medical device used for vascular access and hemostasis during interventional procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K920779 ↗
Decision Date
June 3, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Fast-Cath Hemostasis Introducer was cleared by the FDA through the 510(k) pathway on June 3, 1992. Manufactured by Daig, it is classified as a Class 2 medical device under product code DYB.
What It Is
The Fast-Cath Hemostasis Introducer is a device designed to facilitate vascular access and achieve hemostasis during catheter-based procedures. It consists of a sheath and dilator, allowing for smooth insertion into blood vessels. This device is essential in procedures requiring the introduction of catheters or other instruments into the vascular system, ensuring minimal bleeding and trauma at the access site.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures such as angiography, embolization, and other catheter-based interventions. It is utilized in hospital settings, particularly in catheterization labs, and is suitable for adult patients requiring vascular access. The introducer is crucial for procedures involving the placement of embolization coils or other intravascular devices.
Indications for Use
The Fast-Cath Hemostasis Introducer is indicated for use in patients requiring vascular access for interventional procedures. It is particularly useful in situations where hemostasis is critical, such as during the insertion of embolization coils to treat vascular abnormalities.
Practical Considerations
The Fast-Cath Hemostasis Introducer comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and guidewires, and clinicians should be familiar with the technique of sheath insertion to minimize complications. Proper selection of size and careful handling are essential for optimal outcomes.
Frequently Asked Questions
What is the Fast-Cath Hemostasis Introducer used for?
It is used for vascular access and hemostasis during interventional procedures such as angiography and embolization.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in patients requiring vascular access for interventional procedures, especially where hemostasis is important.
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.