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ptfe super sheath introducer
Martech Medical Products
Summary: The PTFE Super Sheath Introducer is a medical device used to facilitate the insertion of catheters and other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K120617 ↗
Decision Date
November 19, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The PTFE Super Sheath Introducer was cleared through the FDA 510(k) pathway on November 19, 2012. It is manufactured by Martech Medical Products and classified as a Class 2 device under product code DYB.
What It Is
The PTFE Super Sheath Introducer is a thin, flexible tube designed to provide a smooth pathway for the insertion of catheters and other medical devices into the vascular system. Made from polytetrafluoroethylene (PTFE), it offers a low-friction surface that minimizes trauma to blood vessels during procedures. Its design allows for easy navigation through the vascular system, making it a valuable tool in minimally invasive procedures.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and the deployment of embolization coils. It is particularly useful in settings where precise catheter placement is required, such as in the treatment of aneurysms or vascular malformations. The PTFE Super Sheath Introducer is suitable for use in a wide range of patient populations, including those with complex vascular anatomies.
Indications for Use
The FDA indications for the PTFE Super Sheath Introducer include facilitating the introduction of catheters and other devices into the vascular system. It is intended for patients requiring vascular access for diagnostic or therapeutic procedures.
Practical Considerations
The PTFE Super Sheath Introducer is available in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with a wide range of catheters and should be selected based on the specific procedural requirements. Clinicians should ensure proper technique to minimize vascular trauma and optimize device performance.
Frequently Asked Questions
What is the PTFE Super Sheath Introducer used for?
It is used to facilitate the insertion 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 in procedures involving vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system for diagnostic or therapeutic purposes.
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.