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medi-tech percutaneous introducer system
Boston Scientific
Summary: The medi-tech percutaneous introducer system is a medical device used primarily in interventional radiology for the placement of embolization coils. It is utilized by clinicians to access vascular structures safely.
FDA Clearance Information
Pathway
510K
Number
K952828 ↗
Decision Date
August 18, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The medi-tech percutaneous introducer system was cleared via the FDA 510k pathway on August 18, 1995. Manufactured by Boston Scientific, it is classified as a Class 2 device under product code DYB.
What It Is
The medi-tech percutaneous introducer system is a specialized catheter system designed to facilitate the percutaneous insertion of embolization coils into the vascular system. It typically includes a sheath, dilator, and guidewire, allowing for precise vascular access and coil deployment. This system is crucial in minimally invasive procedures, providing a conduit for therapeutic devices to reach target sites within the vasculature.
Clinical Applications
Commonly used in interventional radiology, this device is essential for procedures such as embolization, where it aids in the delivery of coils to occlude blood vessels. It is often employed in the treatment of aneurysms, arteriovenous malformations, and other vascular abnormalities. The system is used in hospital settings, particularly in catheterization labs, and is suitable for adult and pediatric patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures requiring vascular access for the placement of embolization coils. It is indicated for patients needing treatment for vascular abnormalities, such as aneurysms or arteriovenous malformations.
Practical Considerations
The system is available in various sizes to accommodate different patient anatomies and procedural requirements. Compatibility with other interventional devices should be confirmed prior to use. Proper technique in insertion and handling is critical to ensure successful outcomes and minimize complications.
Frequently Asked Questions
What is medi-tech percutaneous introducer system used for?
It is used for the percutaneous insertion of embolization coils into the vascular system, aiding in the treatment of vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings, particularly in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for procedures requiring vascular access for the placement of embolization coils, such as treating aneurysms and arteriovenous 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.