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enpath safety introducer
Enpath Medical
Summary: The Enpath Safety Introducer is a medical device used for the safe introduction of catheters and other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K041708 ↗
Decision Date
November 30, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Enpath Safety Introducer was cleared through the FDA 510(k) pathway on November 30, 2004. It is manufactured by Enpath Medical and classified as a Class 2 device.
What It Is
The Enpath Safety Introducer is designed to facilitate the insertion of catheters and other medical devices into the vascular system. It typically consists of a sheath and a dilator, which help in minimizing trauma to the vessel during insertion. This device is crucial in procedures requiring vascular access, ensuring both safety and efficiency.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Enpath Safety Introducer is employed in procedures such as angiography, embolization, and the placement of central venous catheters. It is used in hospital settings, particularly in catheterization labs and operating rooms, and is suitable for a wide range of patient populations requiring vascular access.
Indications for Use
The device is indicated for use in patients requiring vascular access for procedures like embolization or catheter placement. It is suitable for conditions where safe and efficient vascular entry is critical.
Practical Considerations
The Enpath Safety Introducer comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard catheters and guidewires, and clinicians should be familiar with the insertion technique to minimize complications.
Frequently Asked Questions
What is the Enpath Safety Introducer used for?
It is used for the safe introduction of catheters and other devices into the vascular system.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access, such as embolization and catheter placement.
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.