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scimed 6 french micro-max tm guide catheter
Scimed Life Systems
Summary: The Scimed 6 French Micro-Max TM 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 interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K950094 ↗
Decision Date
March 3, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed 6 French Micro-Max TM Guide Catheter was cleared through the FDA 510(k) pathway on March 3, 1995. It is manufactured by Scimed Life Systems and is classified as a Class 2 medical device.
What It Is
The Scimed 6 French Micro-Max TM Guide Catheter is a flexible tube designed to facilitate the introduction of other devices into the vascular system. It is typically inserted into the femoral artery and navigated to the desired location within the vasculature. The catheter's design allows for precise control and support during procedures, making it a critical tool in endovascular interventions.
Clinical Applications
This guide catheter is commonly used in procedures such as angioplasty, stent placement, and other endovascular interventions. It is particularly useful in cardiology for coronary interventions and in radiology for accessing peripheral vascular regions. The device is suitable for adult patients requiring vascular access for diagnostic or therapeutic purposes.
Indications for Use
The FDA-cleared indications for this device include its use in facilitating the placement of interventional devices within the vascular system. It is intended for patients needing vascular interventions, such as those with coronary artery disease or peripheral vascular disease.
Practical Considerations
The Scimed 6 French Micro-Max TM Guide Catheter is typically available in a 6 French size, which is compatible with a wide range of interventional devices. Clinicians should ensure compatibility with other devices used in the procedure and be familiar with the catheter's handling characteristics to optimize procedural outcomes.
Frequently Asked Questions
What is the Scimed 6 French Micro-Max TM Guide Catheter used for?
It is used to guide other interventional devices into the vascular system during procedures like angioplasty and stent placement.
What specialties typically use this device?
Cardiologists and interventional radiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of interventional devices within the vascular system for patients requiring vascular interventions.
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.