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acuity universal cutter
Cardiac Pacemakers
Summary: The Acuity Universal Cutter is a medical device used for venous stenting procedures. It is typically utilized by interventional cardiologists and vascular surgeons to aid in the placement of stents within veins.
FDA Clearance Information
Pathway
510K
Number
K080154 ↗
Decision Date
March 20, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Acuity Universal Cutter was cleared through the FDA 510k pathway on March 20, 2008. It is manufactured by Cardiac Pacemakers and classified as a Class 2 device under product code DQY.
What It Is
The Acuity Universal Cutter is a specialized tool designed for use in venous stenting procedures. It assists in the precise cutting and preparation of veins to facilitate the placement of stents. The device is engineered to enhance procedural efficiency and accuracy, reducing the risk of complications during stent deployment.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings. It is particularly beneficial in procedures involving the treatment of venous obstructions or insufficiencies, such as in patients with chronic venous insufficiency or post-thrombotic syndrome. The Acuity Universal Cutter is typically used in hospital catheterization labs or specialized vascular centers.
Indications for Use
The FDA-cleared indications for the Acuity Universal Cutter involve its use in venous stenting procedures. It is intended for patients who require stenting to address venous blockages or structural issues within the veins.
Practical Considerations
The Acuity Universal Cutter is compatible with a range of stent sizes and types, making it versatile for various venous applications. Clinicians should be familiar with its operation and ensure compatibility with other procedural equipment. Proper technique is essential to maximize the device's efficacy and minimize patient risk.
Frequently Asked Questions
What is the Acuity Universal Cutter used for?
The Acuity Universal Cutter is used for venous stenting procedures to aid in the placement and deployment of stents within veins.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use the Acuity Universal Cutter in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures to address venous obstructions or structural issues.
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.