📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an introducer for inserting catheters and other instruments into the vascular system.
- Provide hemostasis around an inserted catheter or device during vascular procedures.
- Support vascular access for diagnostic imaging and therapeutic interventions.
Clinical Applications
- Introducing catheters for angiography and other vascular imaging procedures.
- Providing access for embolization procedures, including delivery of embolic materials or coils.
- Maintaining a blood-sealing interface while interventional devices are advanced, exchanged, or withdrawn.
- Use in catheterization laboratories and interventional suites when controlled vascular access is required.
Practical Considerations
- Select the introducer size and valve configuration to match the catheter or device diameter and the access vessel.
- Use standard sterile vascular access technique, with imaging guidance as appropriate for the procedure.
- The valve is intended to reduce blood loss but does not eliminate risks such as bleeding, hematoma, thrombosis, infection, vessel injury, or embolization.
- MRI safety depends on the specific device materials and labeling; confirm the product's current MRI conditions before scanning a patient with the device in place.
- The FDA record is an older 510(k) clearance from 1989. Confirm current availability, instructions for use, shelf life, and compatibility with the manufacturer or facility supply documentation.
Procedures that use this device
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.