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vasostasis vascular closure system
Cardiva Medical
Summary: The Vasostasis Vascular Closure System is a medical device used to achieve hemostasis after vascular procedures. It is primarily used by interventional cardiologists and radiologists to close femoral artery access sites.
FDA Clearance Information
Pathway 510K
Number K041486 ↗
Decision Date October 22, 2004
Product Code DXC
Device Class Class 2
Evidence 0 studies
The Vasostasis Vascular Closure System was cleared through the FDA 510(k) pathway on October 22, 2004. Manufactured by Cardiva Medical, it is classified as a Class 2 device under product code DXC.
What It Is
The Vasostasis Vascular Closure System is designed to facilitate hemostasis following catheterization procedures. It works by applying mechanical pressure to the femoral artery access site, promoting clot formation and reducing bleeding. This device is particularly useful in reducing time to hemostasis and patient recovery time compared to manual compression.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly after procedures such as angiography or percutaneous coronary interventions. It is suitable for patients undergoing diagnostic or therapeutic catheterizations, especially those at risk of bleeding complications. The device is typically used in hospital catheterization labs and outpatient settings.
Indications for Use
The device is indicated for use in patients who have undergone vascular procedures requiring femoral artery access. It is intended to aid in the closure of the access site, thereby reducing bleeding and facilitating quicker recovery.
Practical Considerations
The Vasostasis Vascular Closure System is compatible with standard femoral artery access sizes. Clinicians should be familiar with the device's application technique to ensure effective closure and minimize complications. Training on proper use is recommended to optimize outcomes.
Frequently Asked Questions
What is Vasostasis Vascular Closure System used for?
It is used to achieve hemostasis after vascular procedures involving femoral artery access.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for closure of femoral artery access sites following vascular procedures.
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.