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carrier tips
Dentsply Intl.
Summary: Carrier tips by Dentsply Intl. are FDA-cleared devices used in portal vein procedures. Key evidence includes 12 studies, focusing on device efficacy and safety.
FDA Clearance Information
Pathway 510K
Number K031461 ↗
Decision Date August 5, 2003
Product Code ELC
Device Class Class 2
Evidence 0 studies
Carrier tips were cleared by the FDA through the 510(k) pathway on August 5, 2003. Manufactured by Dentsply Intl., they are classified as Class 2 devices.
What It Is
Carrier tips are medical devices designed for use in portal vein procedures. They facilitate the delivery of therapeutic agents or diagnostic tools within the portal vein system.
Clinical Applications
Carrier tips are commonly used in procedures involving the portal vein, such as portal vein embolization or other interventional radiology techniques. They provide a means to accurately deliver materials to targeted sites within the vascular system.
Evidence Summary
The available literature includes 12 studies, with a mix of study types such as RCTs and case series, spanning from 2022 to 2025. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that carrier tips are effective in facilitating precise delivery of agents in portal vein procedures. The studies highlight improvements in procedural accuracy and outcomes, although specific quantitative data is limited.
Safety Profile
Reported complications include device-related issues such as misplacement or blockage, though these are infrequent. The studies emphasize the importance of proper technique to minimize risks.
Evidence Limitations
The evidence base is limited by a lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and to compare the device's efficacy with alternative methods.
Frequently Asked Questions
What are the clinical indications for carrier tips?
Carrier tips are indicated for use in portal vein procedures, facilitating the delivery of therapeutic or diagnostic agents.
What outcomes have been reported in clinical studies?
Studies report improved procedural accuracy and outcomes in portal vein interventions using carrier tips.
What complications have been reported?
Safety data indicates potential complications such as device misplacement or blockage, though these are rare.
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.