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medi-tech amplatz introducer shealth system
Boston Scientific
Summary: The Medi-Tech Amplatz Introducer Sheath System is a medical device used in interventional radiology and cardiology for vascular access. It is primarily used by clinicians to facilitate the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K891121 ↗
Decision Date
December 5, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medi-Tech Amplatz Introducer Sheath System was cleared through the FDA 510(k) pathway on December 5, 1989. Manufactured by Boston Scientific, it is classified as a Class 2 medical device.
What It Is
The Medi-Tech Amplatz Introducer Sheath System is designed to provide a stable and secure pathway for the insertion of catheters and other interventional devices into the vascular system. It consists of a sheath and dilator, which help in achieving vascular access with minimal trauma. The device is particularly useful in procedures requiring repeated access or the introduction of large-diameter devices.
Clinical Applications
This device is commonly used in interventional radiology and cardiology, particularly in procedures such as angiography, embolization, and the placement of stents or coils. It is suitable for use in both hospital and outpatient settings, and is often employed in patients requiring complex vascular interventions. The sheath system is essential for procedures involving the femoral artery or other large vessels.
Indications for Use
The FDA-cleared indications for the Medi-Tech Amplatz Introducer Sheath System include facilitating the introduction of catheters and other devices into the vascular system. It is intended for use in patients undergoing procedures that require vascular access, such as angiographic studies or interventional treatments.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and interventional tools, making it versatile for different clinical scenarios. Proper technique in insertion and maintenance of the sheath is crucial to minimize complications such as vascular injury or infection.
Frequently Asked Questions
What is the Medi-Tech Amplatz Introducer Sheath System used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device for vascular access during various procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other interventional devices into the vascular system.
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.