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rapid-trak tm introducer sheath
Cardio Vascular Concepts
Summary: The Rapid-Trak TM Introducer Sheath is a medical device used in embolization procedures. It is FDA 510k cleared and linked to 7 studies, providing insights into its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K950155 ↗
Decision Date
August 2, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Rapid-Trak TM Introducer Sheath was cleared by the FDA via the 510k pathway on August 2, 1995. It is manufactured by Cardio Vascular Concepts and classified as a Class 2 device.
What It Is
The Rapid-Trak TM Introducer Sheath is a device designed to facilitate the introduction of catheters and other instruments into the vascular system. It is primarily used in embolization procedures to provide access to targeted areas within the vasculature.
Clinical Applications
Commonly used in procedures involving embolization coils, the Rapid-Trak TM Introducer Sheath is utilized in interventional radiology and cardiology to ensure precise delivery of therapeutic agents or devices into the vascular system.
Evidence Summary
The available literature includes 7 studies, encompassing various study types such as RCTs and case series, published between 2022 and 2024. These studies provide insights into the device's clinical applications and safety.
Reported Outcomes
Published studies report that the Rapid-Trak TM Introducer Sheath is effective in facilitating vascular access during embolization procedures. The device has been associated with successful delivery of embolization coils, contributing to positive procedural outcomes.
Safety Profile
Reported complications include potential technical pitfalls during deployment, as noted in some studies. However, the overall safety profile is considered acceptable, with no significant adverse events directly attributed to the device.
Evidence Limitations
The evidence is limited by the small number of studies specifically focusing on the Rapid-Trak TM Introducer Sheath. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Rapid-Trak TM Introducer Sheath?
The device is indicated for use in embolization procedures, particularly for facilitating the introduction of catheters and other instruments into the vascular system.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of vascular access and successful delivery of embolization coils, contributing to positive procedural outcomes.
What complications have been reported?
Reported complications include potential technical pitfalls during deployment, but no significant adverse events have been directly attributed to the device.
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.