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acs powerbase tm coronary guiding catheter
Advanced Cardiovascular Systems
Summary: The ACS Powerbase TM Coronary Guiding Catheter is a medical device used in interventional cardiology to guide other instruments into the coronary arteries. It is primarily used by cardiologists during procedures like angioplasty.
FDA Clearance Information
Pathway
510K
Number
K940559 ↗
Decision Date
May 3, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ACS Powerbase TM Coronary Guiding Catheter was cleared through the FDA 510k pathway on May 3, 1994. It is manufactured by Advanced Cardiovascular Systems and classified as a Class 2 device.
What It Is
The ACS Powerbase TM Coronary Guiding Catheter is a specialized catheter designed to navigate the coronary arteries and facilitate the delivery of interventional devices like balloons and stents. It is constructed to provide support and stability during procedures, ensuring precise placement of therapeutic devices. Its design allows for optimal torque control and flexibility, which are critical for navigating the complex coronary anatomy.
Clinical Applications
This catheter is commonly used in interventional cardiology, particularly during percutaneous coronary interventions (PCI) such as angioplasty and stent placement. It is utilized in hospital catheterization labs by interventional cardiologists. The device is suitable for a wide range of patients requiring coronary artery interventions, including those with coronary artery disease.
Indications for Use
The FDA indications for this device involve its use in guiding other instruments into the coronary arteries during interventional procedures. It is intended for patients who require coronary interventions, such as those with blockages or narrowing of the coronary arteries.
Practical Considerations
The ACS Powerbase TM Coronary Guiding Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard interventional cardiology equipment. Clinicians should be familiar with catheter handling techniques to ensure optimal performance and patient safety.
Frequently Asked Questions
What is ACS Powerbase TM Coronary Guiding Catheter used for?
It is used to guide other interventional devices into the coronary arteries during procedures like angioplasty and stent placement.
What specialties typically use this device?
Interventional cardiologists typically use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for guiding instruments into the coronary arteries during interventional procedures for patients with coronary artery disease.
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.