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microcruiser plus introducer set
Medical Device Technologies
Summary: The Microcruiser Plus Introducer Set is a medical device used primarily in interventional radiology for the placement of embolization coils. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K011790 ↗
Decision Date
September 5, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Microcruiser Plus Introducer Set was cleared through the FDA 510(k) pathway on September 5, 2001. It is manufactured by Medical Device Technologies and classified as a Class II device under product code DYB.
What It Is
The Microcruiser Plus Introducer Set is a specialized medical device designed to facilitate the introduction of embolization coils into the vascular system. It typically consists of a sheath and dilator, allowing for smooth insertion and navigation within blood vessels. This device is crucial in procedures aiming to occlude blood flow to specific areas, often to treat aneurysms or other vascular abnormalities.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Microcruiser Plus Introducer Set is employed in procedures requiring precise placement of embolization coils. These procedures are often performed in hospital settings, targeting conditions such as cerebral aneurysms or arteriovenous malformations. The device is suitable for a wide range of patient populations, including those with complex vascular conditions.
Indications for Use
The FDA-cleared indications for this device involve its use in delivering embolization coils to occlude blood vessels. It is indicated for patients requiring intervention to prevent blood flow to aneurysms or other vascular anomalies.
Practical Considerations
The Microcruiser Plus Introducer Set is available in various sizes to accommodate different vessel diameters. Compatibility with other interventional tools should be considered, and clinicians should be trained in the specific techniques for its use to ensure optimal outcomes.
Frequently Asked Questions
What is the Microcruiser Plus Introducer Set used for?
It is used to facilitate the introduction of embolization coils into the vascular system to occlude blood flow to specific areas.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in procedures involving vascular access and embolization.
What are the FDA-cleared indications?
The device is indicated for use in delivering embolization coils to occlude blood vessels, particularly in treating aneurysms or vascular malformations.
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.