đź“‹ FDA Reference
angeion hemostasis valve introducer
Angeion
Summary: The Angeion Hemostasis Valve Introducer is a medical device used to facilitate the introduction of catheters and other devices into the vascular system while minimizing blood loss. It is commonly used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K894446 ↗
Decision Date
November 30, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Angeion Hemostasis Valve Introducer was cleared through the FDA 510(k) pathway on November 30, 1989. It is manufactured by Angeion and classified as a Class 2 device under product code DYB.
What It Is
The Angeion Hemostasis Valve Introducer is a device designed to provide a seal around catheters and other interventional tools as they are inserted into the vascular system. It helps to minimize blood loss and maintain a clean field during procedures. The device typically consists of a valve mechanism that allows for smooth insertion and withdrawal of instruments while maintaining hemostasis.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures such as angiography, embolization, and the placement of embolization coils. It is used in hospital settings, particularly in catheterization labs and interventional suites. The device is suitable for a wide range of patient populations requiring vascular access for diagnostic or therapeutic procedures.
Indications for Use
The FDA-cleared indications for the Angeion Hemostasis Valve Introducer include its use in procedures requiring vascular access, such as the introduction of catheters for diagnostic imaging or therapeutic interventions. It is indicated for patients who need controlled vascular access with minimal blood loss.
Practical Considerations
The Angeion Hemostasis Valve Introducer comes in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with standard interventional tools and requires familiarity with vascular access techniques. Clinicians should ensure proper sizing and secure placement to maintain hemostasis.
Frequently Asked Questions
What is the Angeion Hemostasis Valve Introducer used for?
The device is used to facilitate the introduction of catheters and other interventional tools into the vascular system while minimizing blood loss.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as catheter introduction for diagnostic or therapeutic purposes, with minimal blood loss.
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.