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arstasis one latchwire access system
Arstasis
Summary: The Arstasis One Latchwire Access System is a medical device used for vascular access in interventional procedures. It is primarily utilized by interventional cardiologists and radiologists for procedures requiring arterial access.
FDA Clearance Information
Pathway
510K
Number
K103143 ↗
Decision Date
February 2, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Arstasis One Latchwire Access System was cleared through the FDA 510(k) pathway on February 2, 2011. Manufactured by Arstasis, it is classified as a Class 2 device under product code DYB.
What It Is
The Arstasis One Latchwire Access System is designed to facilitate arterial access during interventional procedures. It employs a unique latchwire mechanism that aids in the precise placement of guidewires into the vascular system. This device is particularly useful in minimizing trauma to the arterial wall, potentially reducing complications associated with vascular access.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures such as angiography, stent placement, and embolization. It is suitable for use in hospitals and specialized clinics where minimally invasive vascular procedures are performed. The system is beneficial for patients requiring precise and reliable arterial access, including those undergoing diagnostic or therapeutic interventions.
Indications for Use
The FDA indications suggest that the device is intended for use in procedures requiring vascular access, particularly in the placement of embolization coils. It is suitable for patients who need precise arterial access for interventional treatments.
Practical Considerations
The Arstasis One Latchwire Access System is typically compatible with standard guidewires and catheters used in vascular procedures. Clinicians should be familiar with the latchwire mechanism to ensure proper technique and minimize complications. It is important to select the appropriate size based on the patient's anatomy and the specific procedure.
Frequently Asked Questions
What is the Arstasis One Latchwire Access System used for?
It is used for obtaining arterial access in interventional procedures, such as angiography and stent placement.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, particularly for the placement of 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.