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scimed 8 french big-max guide catheter
Scimed Life Systems
Summary: The Scimed 8 French Big-Max Guide Catheter is a medical device used in interventional cardiology and radiology to facilitate the placement of other devices like stents. It is primarily used by cardiologists and radiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K943777 ↗
Decision Date
October 13, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed 8 French Big-Max Guide Catheter was cleared through the FDA's 510(k) pathway on October 13, 1994. It is manufactured by Scimed Life Systems and classified as a Class 2 medical device.
What It Is
The Scimed 8 French Big-Max Guide Catheter is a flexible tube designed to provide a pathway for other medical devices to be delivered to specific areas within the vascular system. It is typically used to guide stents or other therapeutic devices to the site of a vascular lesion. The catheter's design allows for precise navigation through the vascular system, minimizing trauma to the vessel walls.
Clinical Applications
This guide catheter is commonly used in interventional cardiology and radiology procedures, such as percutaneous coronary interventions (PCI) and endovascular stent placements. It is utilized in hospital settings, particularly in catheterization labs, and is essential for procedures involving complex vascular anatomy. The device is suitable for adult patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for the Scimed 8 French Big-Max Guide Catheter include facilitating the placement of stents and other devices within the vascular system. It is intended for patients with conditions requiring vascular access and intervention, such as coronary artery disease.
Practical Considerations
The 8 French size refers to the outer diameter of the catheter, which is compatible with a variety of interventional devices. Clinicians should ensure compatibility with the specific devices being used in the procedure. Proper technique in navigating the catheter through the vascular system is crucial to avoid vessel injury.
Frequently Asked Questions
What is the Scimed 8 French Big-Max Guide Catheter used for?
It is used to facilitate the placement of stents and other devices in the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of stents and other devices within the vascular system for patients requiring vascular intervention.
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.