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medtronic 5f 9f zuma guiding catheters
Medtronics Interventional Vascular
Summary: The Medtronic 5F 9F Zuma Guiding Catheters are used in interventional vascular procedures to guide other devices through blood vessels. They are primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K990707 ↗
Decision Date
March 22, 1999
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Medtronic 5F 9F Zuma Guiding Catheters were cleared through the FDA 510(k) pathway on March 22, 1999. Manufactured by Medtronics Interventional Vascular, these devices are classified as Class 2 under product code DQY.
What It Is
The Medtronic 5F 9F Zuma Guiding Catheters are flexible, tube-like medical devices designed to navigate through the vascular system. They provide a conduit for other instruments, such as stents or balloons, to reach target areas within the blood vessels. These catheters are essential in procedures requiring precise placement and support of interventional tools.
Clinical Applications
These guiding catheters are commonly used in interventional cardiology and radiology for procedures such as angioplasty or stent placement. They are crucial in settings like cardiac catheterization labs and are used for patients requiring vascular interventions, including those with coronary artery disease or peripheral vascular disease.
Indications for Use
The FDA indications suggest that these catheters are intended for use in guiding other devices during vascular procedures. They are suitable for patients needing interventions to treat or manage vascular conditions.
Practical Considerations
The catheters come in various sizes, typically ranging from 5F to 9F, to accommodate different vessel sizes and procedural needs. They are compatible with a range of interventional devices and require careful handling to ensure precise navigation and placement.
Frequently Asked Questions
What is Medtronic 5F 9F Zuma Guiding Catheters used for?
These catheters are used to guide other medical devices through blood vessels during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use these guiding catheters.
What are the FDA-cleared indications?
The catheters are indicated for use in guiding devices during vascular procedures, suitable for patients with vascular conditions.
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.