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acuity break-away guide catheter
Cardiac Pacemakers
Summary: The acuity break-away guide catheter is a medical device used primarily in cardiology for the placement of venous stents. It is typically used by interventional cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K093969 ↗
Decision Date
March 5, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The acuity break-away guide catheter was cleared through the FDA 510(k) pathway on March 5, 2010. It is manufactured by Cardiac Pacemakers and classified as a Class II device.
What It Is
The acuity break-away guide catheter is a specialized catheter designed to facilitate the placement of venous stents. It features a break-away mechanism that allows for easier navigation and positioning within the venous system. This device is particularly useful in complex procedures where precise catheter placement is critical.
Clinical Applications
This device is commonly used in interventional cardiology, particularly during procedures involving the placement of stents in the venous system. It is often utilized in hospital catheterization labs where precision and stability are required. Patients with conditions such as venous insufficiency or those requiring venous access for other interventions may benefit from its use.
Indications for Use
The acuity break-away guide catheter is indicated for use in patients requiring venous stenting. It is suitable for those with venous blockages or other conditions necessitating the placement of a stent to maintain or restore venous flow.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard stenting equipment and requires careful handling to ensure proper break-away functionality during procedures.
Frequently Asked Questions
What is the acuity break-away guide catheter used for?
It is used for facilitating the placement of venous stents in interventional cardiology procedures.
What specialties typically use this device?
Interventional cardiologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for use in patients requiring venous stenting, such as those with venous blockages.
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.