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2f 3f vascu-sheath tearaway introducer
Medical Components
Summary: The 2f 3f Vascu-Sheath Tearaway Introducer is a medical device used for vascular access, primarily by interventional radiologists and cardiologists. It facilitates the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K130687 ↗
Decision Date
August 15, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The 2f 3f Vascu-Sheath Tearaway Introducer was cleared through the FDA 510(k) pathway on August 15, 2013. It is manufactured by Medical Components and is classified as a Class 2 device under product code DYB.
What It Is
The 2f 3f Vascu-Sheath Tearaway Introducer is a specialized medical device designed to provide access to the vascular system. It consists of a sheath that can be easily torn away to facilitate the insertion of catheters and other interventional devices. This device is particularly useful in procedures requiring precise vascular access, offering a streamlined method for introducing various instruments into the bloodstream.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, angiography, and catheter placement. It is particularly useful in hospital settings where quick and reliable vascular access is necessary. The introducer is suitable for a wide range of patient populations, including those requiring minimally invasive procedures to manage vascular conditions.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring vascular access, such as the introduction of embolization coils. It is suitable for patients needing interventions to address vascular abnormalities or conditions.
Practical Considerations
The 2f 3f Vascu-Sheath Tearaway Introducer typically comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and devices commonly used in vascular interventions. Clinicians should be familiar with the tearaway technique to ensure efficient and safe device deployment.
Frequently Asked Questions
What is the 2f 3f Vascu-Sheath Tearaway Introducer used for?
It is used for providing vascular access to facilitate the introduction of catheters and other interventional devices.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access, such as the introduction of embolization coils.
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.