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acs powerguide coronary guiding catheter
Advanced Cardiovascular Systems
Summary: The ACS PowerGuide Coronary Guiding Catheter is a medical device used in coronary interventions to guide other instruments to the heart's blood vessels. It is primarily used by interventional cardiologists.
FDA Clearance Information
Pathway
510K
Number
K934009 ↗
Decision Date
January 11, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ACS PowerGuide Coronary Guiding Catheter was cleared via the FDA 510(k) pathway on January 11, 1994. Manufactured by Advanced Cardiovascular Systems, it is classified as a Class 2 device.
What It Is
The ACS PowerGuide Coronary Guiding Catheter is a specialized catheter designed to provide support and guidance for other interventional devices during coronary procedures. It is inserted into the vascular system and navigated to the coronary arteries. The catheter's design allows for precise placement and stability, facilitating the delivery of balloons, stents, and other therapeutic devices.
Clinical Applications
This device is commonly used in percutaneous coronary interventions (PCI), where it serves as a conduit for devices used to treat coronary artery disease. Interventional cardiologists use it in catheterization labs to perform angioplasty and stent placements. It is particularly useful in patients with complex coronary anatomy or those requiring multiple device exchanges.
Indications for Use
The ACS PowerGuide is indicated for use in patients undergoing coronary interventions. It is designed to assist in the placement of interventional devices within the coronary arteries, making it suitable for patients with coronary artery disease requiring revascularization.
Practical Considerations
The catheter comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and interventional devices. Clinicians should be familiar with catheter manipulation techniques to ensure successful navigation and device delivery.
Frequently Asked Questions
What is the ACS PowerGuide Coronary Guiding Catheter used for?
It is used to guide and support interventional devices during coronary procedures, such as angioplasty and stent placement.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs during coronary interventions.
What are the FDA-cleared indications?
The device is indicated for use in coronary interventions to assist in the placement of therapeutic devices within the coronary arteries.
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.