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usci uncoated guiding catheters
C.R. Bard
Summary: The USCI Uncoated Guiding Catheters by C.R. Bard are used in interventional cardiology to facilitate the introduction of interventional devices into the vascular system. They are primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K894682 ↗
Decision Date
September 12, 1989
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The USCI Uncoated Guiding Catheters were cleared through the FDA 510(k) pathway on September 12, 1989. Manufactured by C.R. Bard, this device is classified as a Class 2 medical device under product code DQY.
What It Is
The USCI Uncoated Guiding Catheters are medical devices designed to provide a conduit for the introduction of interventional devices into the vascular system. They are typically used in procedures requiring precise navigation through the vascular anatomy, such as angioplasty or stent placement. These catheters are uncoated, which may influence their frictional properties and handling characteristics.
Clinical Applications
These guiding catheters are commonly used in interventional cardiology and radiology for procedures such as angioplasty, stent deployment, and other vascular interventions. They are essential in settings like cardiac catheterization labs and interventional radiology suites. The primary patient population includes those with coronary artery disease or other vascular conditions requiring intervention.
Indications for Use
The FDA indications suggest that these catheters are intended for use in facilitating the introduction of diagnostic or therapeutic devices into the vascular system. This typically includes patients undergoing procedures for coronary artery disease or peripheral vascular disease.
Practical Considerations
Clinicians should consider the catheter's size and compatibility with other devices when planning procedures. The uncoated nature of the catheter may affect its handling and friction, requiring careful manipulation during use. It is important to select the appropriate size and shape based on the patient's vascular anatomy.
Frequently Asked Questions
What is USCI Uncoated Guiding Catheters used for?
They are used to facilitate the introduction of diagnostic or therapeutic devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and interventional radiologists typically use these catheters.
What are the FDA-cleared indications?
The catheters are indicated for use in facilitating the introduction of devices into the vascular system, commonly for procedures addressing coronary artery disease or peripheral vascular 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.