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devices for vascu intervent rotat hemostat valve
Devices For Vascular Intervention
Summary: The rotational hemostat valve by Devices For Vascular Intervention is used in vascular procedures to control blood flow during catheterization. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K914422 ↗
Decision Date
December 18, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on December 18, 1991. It is manufactured by Devices For Vascular Intervention and classified as a Class 2 device.
What It Is
The rotational hemostat valve is a medical device designed to manage blood flow during vascular interventions. It functions by providing a secure seal around catheters, allowing for controlled access to blood vessels while minimizing blood loss. This device is particularly useful in procedures requiring multiple catheter exchanges or adjustments.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is essential during procedures like angioplasty or stent placement. It is used in hospital settings, particularly in catheterization labs, to manage patients with vascular diseases. The device is suitable for adult patients undergoing venous interventions.
Indications for Use
The device is indicated for use in procedures requiring vascular access and control of blood flow. It is particularly beneficial for patients undergoing venous stent placements or similar interventions.
Practical Considerations
The rotational hemostat valve is compatible with a range of catheter sizes, making it versatile for various procedures. Clinicians should ensure proper technique to maintain a secure seal and prevent blood leakage during catheter exchanges.
Frequently Asked Questions
What is the rotational hemostat valve used for?
It is used to control blood flow during vascular interventions, particularly in catheterization procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is cleared for use in controlling blood flow during vascular access procedures, such as venous stent placements.
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.