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new usci 7f ptca guiding catheter
C.R. Bard
Summary: The USCI 7F PTCA Guiding Catheter by C.R. Bard is a medical device used in percutaneous transluminal coronary angioplasty (PTCA) procedures. It is primarily used by cardiologists to guide other instruments to the coronary arteries.
FDA Clearance Information
Pathway
510K
Number
K905249 ↗
Decision Date
February 19, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The USCI 7F PTCA Guiding Catheter was cleared through the FDA 510(k) pathway on February 19, 1991. Manufactured by C.R. Bard, this device is classified as Class 2 under product code DQY.
What It Is
The USCI 7F PTCA Guiding Catheter is a specialized catheter designed to facilitate the delivery of interventional devices to the coronary arteries during PTCA procedures. It provides support and a conduit for other instruments, such as balloon catheters and stents, to reach the target site. The catheter's design ensures optimal torque control and stability during navigation through the vascular system.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology, particularly during PTCA procedures to treat coronary artery disease. It is utilized in hospital settings, primarily in catheterization labs, by interventional cardiologists. The device is suitable for adult patients requiring coronary intervention, especially those with significant coronary artery blockages.
Indications for Use
The USCI 7F PTCA Guiding Catheter is indicated for use in procedures that require access to the coronary arteries, such as angioplasty. It is intended for patients with coronary artery disease who need interventional treatment to restore blood flow.
Practical Considerations
The USCI 7F PTCA Guiding Catheter typically comes in various lengths and shapes to accommodate different anatomical needs and procedural requirements. It is compatible with standard PTCA equipment and requires careful handling to ensure precise navigation and placement.
Frequently Asked Questions
What is the USCI 7F PTCA Guiding Catheter used for?
It is used in percutaneous transluminal coronary angioplasty (PTCA) procedures to guide instruments to the coronary arteries.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in coronary angioplasty procedures to facilitate access and treatment of 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.