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acs powerbase guilding catheter
Advanced Cardiovascular Systems
Summary: The ACS Powerbase Guiding Catheter is a medical device used primarily in interventional cardiology for guiding other instruments into the vascular system. It is typically used by cardiologists during procedures such as angioplasty.
FDA Clearance Information
Pathway
510K
Number
K952205 ↗
Decision Date
August 4, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ACS Powerbase Guiding Catheter was cleared through the FDA 510(k) pathway on August 4, 1995, by Advanced Cardiovascular Systems. It is classified as a Class 2 device under product code DQY.
What It Is
The ACS Powerbase Guiding Catheter is designed to facilitate the placement of interventional devices within the vascular system. It provides support and stability for the passage of other catheters and instruments during procedures. The catheter's design allows for precise navigation through the vascular anatomy, making it an essential tool in complex interventions.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology, particularly during procedures like coronary angioplasty and stent placement. It is utilized in hospital settings, primarily in catheterization labs, and is essential for procedures involving coronary arteries. The device is used in adult patients who require vascular interventions.
Indications for Use
The FDA-cleared indications for the ACS Powerbase Guiding Catheter include its use in facilitating the placement of interventional devices during vascular procedures. It is intended for patients undergoing procedures that require access to the coronary arteries.
Practical Considerations
The ACS Powerbase Guiding Catheter comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard interventional devices and requires careful handling to maintain sterility and functionality during procedures.
Frequently Asked Questions
What is the ACS Powerbase Guiding Catheter used for?
It is used to guide interventional devices into the vascular system during procedures like angioplasty.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
The catheter is indicated for use in facilitating the placement of interventional devices during vascular procedures, particularly in coronary interventions.
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.