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scimed 6 french micro-max guide catheter
Scimed
Summary: The Scimed 6 French Micro-Max Guide Catheter is a medical device used primarily in interventional cardiology and radiology for guiding other instruments into the vascular system. It is typically used by cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K953909 ↗
Decision Date
November 13, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed 6 French Micro-Max Guide Catheter was cleared through the FDA 510(k) pathway on November 13, 1995. It is manufactured by Scimed and classified as a Class 2 device under product code DQY.
What It Is
The Scimed 6 French Micro-Max Guide Catheter is a flexible tube designed to facilitate the introduction and guidance of other medical devices into the vascular system. It is typically used in procedures that require access to the venous system, such as the placement of stents or other interventional devices. The catheter's design allows for precise navigation through blood vessels, making it an essential tool in minimally invasive procedures.
Clinical Applications
This guide catheter is commonly used in interventional cardiology and radiology procedures, particularly those involving the placement of venous stents. It is used in hospital settings, often in catheterization labs, and is essential for procedures involving patients with vascular conditions. The device is suitable for adult patients requiring vascular intervention.
Indications for Use
The FDA indications suggest that this catheter is intended for use in guiding other devices into the venous system. It is particularly useful for patients requiring stent placement or other vascular interventions.
Practical Considerations
The Scimed 6 French Micro-Max Guide Catheter is typically available in various lengths to accommodate different procedural needs. It is compatible with standard interventional tools and requires careful handling to ensure precise navigation through the vascular system. Clinicians should be familiar with catheterization techniques to optimize its use.
Frequently Asked Questions
What is the Scimed 6 French Micro-Max Guide Catheter used for?
It is used to guide other medical devices into the vascular system, primarily for venous stent placement and other interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The catheter is indicated for guiding devices into the venous system, particularly for procedures involving stent placement.
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.