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acs rotating hemostatic valve acs duostat rotating hemostatic valve
Advanced Cardiovascular Systems
Summary: The ACS Rotating Hemostatic Valve is a medical device used to prevent blood loss during catheter-based procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K934624 ↗
Decision Date
April 13, 1994
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The ACS Rotating Hemostatic Valve was cleared via the FDA 510k pathway on April 13, 1994. Manufactured by Advanced Cardiovascular Systems, it is classified as a Class 2 device.
What It Is
The ACS Rotating Hemostatic Valve is designed to maintain hemostasis during catheterization procedures by providing a seal around the catheter. This device allows for the introduction and manipulation of interventional tools while minimizing blood loss. It features a rotating mechanism to ensure a secure fit around various catheter sizes, enhancing procedural efficiency and safety.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures such as angioplasty or embolization. It is suitable for use in hospitals and specialized cardiac catheterization labs. The valve is beneficial for patients undergoing procedures that require repeated catheter exchanges or adjustments.
Indications for Use
The ACS Rotating Hemostatic Valve is indicated for use in procedures requiring vascular access and catheter manipulation, such as those involving embolization coils. It is designed to prevent blood loss and maintain a sterile field during these interventions.
Practical Considerations
The device typically accommodates a range of catheter sizes, making it versatile for various procedures. Clinicians should ensure compatibility with existing catheter systems and be familiar with the rotating mechanism to optimize its use. Proper technique in securing the valve is essential to maintain hemostasis.
Frequently Asked Questions
What is the ACS Rotating Hemostatic Valve used for?
It is used to prevent blood loss during catheter-based procedures by providing a seal around the catheter.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access and catheter manipulation, such as those involving embolization coils.
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.