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mynx vascular closure device product family
Cordis Us
Summary: The Mynx Vascular Closure Device is used to seal vascular access sites post-catheterization procedures. It is primarily used by interventional cardiologists and radiologists to achieve hemostasis.
FDA Clearance Information
Pathway PMA
Number P040044 ↗
Decision Date April 30, 2014
Product Code MGB
Device Class Class 3
Evidence 0 studies
The Mynx Vascular Closure Device, manufactured by Cordis Us, received FDA clearance under PMA P040044 on April 30, 2014. It is a Class 3 medical device.
What It Is
The Mynx Vascular Closure Device is designed to close femoral artery access sites following catheterization procedures. It uses a polyethylene glycol (PEG) sealant that expands upon contact with blood, creating a secure closure. This device helps reduce time to hemostasis and ambulation, improving patient comfort and reducing complications associated with manual compression.
Clinical Applications
The device is commonly used in interventional cardiology and radiology settings, particularly after procedures such as angiography, angioplasty, and stent placements. It is suitable for patients undergoing these procedures who require quick and effective closure of the vascular access site to minimize bleeding and promote faster recovery. The device is often used in hospitals and outpatient catheterization labs.
Indications for Use
The FDA indications for the Mynx Vascular Closure Device involve reducing the time and complexity of achieving hemostasis at femoral artery access sites. It is indicated for patients who have undergone catheter-based procedures and require effective vascular closure.
Practical Considerations
The Mynx device is available in various sizes to accommodate different sheath sizes used during procedures. It is compatible with standard catheterization techniques and requires proper training for effective deployment. Clinicians should be aware of the patient's vascular anatomy and any potential contraindications such as severe peripheral vascular disease.
Frequently Asked Questions
What is Mynx Vascular Closure Device used for?
It is used to seal femoral artery access sites following catheterization procedures to achieve hemostasis.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for reducing the time and complexity of achieving hemostasis at femoral artery access sites post-catheterization.
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.