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usci super 6 6f ptca guiding catheter
C.R. Bard
Summary: The usci super 6 6f PTCA guiding catheter by C.R. Bard is used in percutaneous transluminal coronary angioplasty (PTCA) procedures. It is primarily utilized by interventional cardiologists to guide other devices into coronary arteries.
FDA Clearance Information
Pathway
510K
Number
K933019 ↗
Decision Date
September 28, 1993
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The usci super 6 6f PTCA guiding catheter was cleared through the FDA 510(k) pathway on September 28, 1993. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code DQY.
What It Is
The usci super 6 6f PTCA guiding catheter is a specialized catheter designed for use in coronary angioplasty procedures. It provides support and guidance for other interventional devices, such as balloon catheters and stents, into the coronary arteries. The catheter's design allows for precise navigation and positioning within the vascular system, facilitating effective treatment of coronary artery disease.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology during procedures to treat coronary artery disease. It is employed in settings such as cardiac catheterization labs, where it assists in the delivery of therapeutic devices to the coronary arteries. The device is suitable for adult patients undergoing PTCA to improve blood flow in blocked or narrowed coronary arteries.
Indications for Use
The FDA-cleared indications for this device involve its use in guiding other devices during PTCA procedures. It is intended for patients with coronary artery disease who require intervention to restore adequate blood flow to the heart muscle.
Practical Considerations
The usci super 6 6f PTCA guiding catheter typically comes in a 6 French size, which is compatible with standard interventional devices. Clinicians should be familiar with catheter manipulation techniques to ensure optimal placement and performance during procedures.
Frequently Asked Questions
What is usci super 6 6f PTCA guiding catheter used for?
It is used to guide interventional devices into coronary arteries during PTCA procedures.
What specialties typically use this device?
Interventional cardiologists typically use this device in cardiac catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in guiding devices during PTCA procedures for coronary artery disease treatment.
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.