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valved tearway introducer
Medcomp
Summary: The valved tearway introducer by Medcomp is a device used primarily in embolization procedures. It is FDA 510k cleared and supported by 10 studies, focusing on its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K090394 ↗
Decision Date
September 1, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The valved tearway introducer was cleared by the FDA through the 510k pathway on September 1, 2009. It is manufactured by Medcomp and classified as a Class 2 medical device.
What It Is
The valved tearway introducer is a medical device designed to facilitate the introduction of catheters or other devices into the vascular system. It features a valve mechanism to prevent blood loss during procedures and is primarily used in embolization-coil applications.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures requiring vascular access, such as embolization. It is particularly useful in scenarios where maintaining hemostasis is critical.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series, published between 2009 and 2025. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the valved tearway introducer is effective in maintaining vascular access with minimal blood loss. It has been successfully used in complex interventional procedures, demonstrating reliability and ease of use.
Safety Profile
Reported complications include potential vascular injury and thrombosis, which are inherent risks in procedures involving vascular access. However, the device's design aims to minimize these risks.
Evidence Limitations
The available evidence is limited by the small sample sizes and lack of long-term follow-up in some studies. Further research is needed to fully understand the device's long-term safety and efficacy.
Frequently Asked Questions
What are the clinical indications for valved tearway introducer?
The device is indicated for use in procedures requiring vascular access, such as embolization-coil applications.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vascular access with minimal blood loss and successful use in complex procedures.
What complications have been reported?
Safety data indicate potential risks of vascular injury and thrombosis, although these are minimized by the device's design.
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.