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stiffer coaxial micro-introducer kit
Enpath Medical
Summary: The stiffer coaxial micro-introducer kit is a medical device used primarily by interventional radiologists for procedures involving embolization coils. It facilitates the introduction of devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K071574 ↗
Decision Date
July 5, 2007
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on July 5, 2007. Manufactured by Enpath Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The stiffer coaxial micro-introducer kit is a specialized tool designed to aid in the insertion of medical devices into the vascular system. It consists of a sheath and dilator that provide a stable and controlled pathway for the introduction of embolization coils and other interventional tools. Its stiffer construction allows for enhanced control and precision during procedures.
Clinical Applications
This device is commonly used in interventional radiology, particularly in procedures that require the placement of embolization coils to treat vascular abnormalities such as aneurysms or arteriovenous malformations. It is typically used in hospital settings by specialists trained in minimally invasive techniques, often involving adult and pediatric patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device include its use in facilitating the introduction of embolization coils into the vascular system. It is intended for patients needing treatment for conditions like aneurysms or other vascular abnormalities.
Practical Considerations
Clinicians should be aware of the typical sizing options available for this device to ensure compatibility with the specific embolization coils being used. Proper technique in handling the sheath and dilator is crucial for successful device placement and patient safety.
Frequently Asked Questions
What is the stiffer coaxial micro-introducer kit used for?
It is used to facilitate the introduction of embolization coils into the vascular system during interventional radiology procedures.
What specialties typically use this device?
Interventional radiologists primarily use this device in hospital settings for vascular interventions.
What are the FDA-cleared indications?
The device is indicated for use in introducing embolization coils into the vascular system to treat conditions such as aneurysms.
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.