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ptfe super sheath introducer
Martech Medical Products
Summary: The PTFE Super Sheath Introducer is a medical device used primarily in interventional radiology and cardiology for vascular access. It is utilized by clinicians to facilitate the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K130855 ↗
Decision Date
July 29, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The PTFE Super Sheath Introducer was cleared via the FDA 510(k) pathway on July 29, 2013. Manufactured by Martech Medical Products, it is classified as a Class 2 device under product code DYB.
What It Is
The PTFE Super Sheath Introducer is a tubular device designed to provide a conduit for the insertion of catheters and other instruments into the vascular system. Made from polytetrafluoroethylene (PTFE), it offers a smooth, low-friction surface that minimizes trauma to the vessel wall during insertion. This device is crucial for procedures requiring stable and reliable vascular access.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is essential for procedures such as angiography, embolization, and the deployment of embolization coils. It is typically employed in hospital settings, particularly in catheterization labs, and is used for patients requiring minimally invasive vascular interventions.
Indications for Use
The PTFE Super Sheath Introducer is indicated for use in patients requiring vascular access for the introduction of diagnostic or therapeutic devices. It is suitable for a variety of conditions where minimally invasive vascular procedures are necessary.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with a range of catheters and guidewires, and clinicians should ensure proper sizing and technique to minimize complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the PTFE Super Sheath Introducer used for?
It is used to facilitate the introduction of catheters and other instruments into the vascular system for diagnostic or therapeutic procedures.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that utilize this device.
What are the FDA-cleared indications?
The device is indicated for vascular access to introduce diagnostic or therapeutic 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.