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french 7 tri-access compact central vein
Cardio-Vascular Innovations
Summary: The French 7 Tri-Access Compact Central Vein by Cardio-Vascular Innovations is a Class 2 medical device cleared by the FDA for central venous access. Key evidence includes studies on device efficacy and safety in embolization procedures.
FDA Clearance Information
Pathway
510K
Number
K843500 ↗
Decision Date
October 18, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The French 7 Tri-Access Compact Central Vein was cleared through the FDA 510k pathway on October 18, 1984. It is manufactured by Cardio-Vascular Innovations and classified as a Class 2 device.
What It Is
The French 7 Tri-Access Compact Central Vein is a medical device designed for central venous access, primarily used in embolization procedures. It facilitates the introduction of embolization coils into the vasculature.
Clinical Applications
This device is commonly used in clinical scenarios requiring central venous access, such as in the management of vascular embolization. It is particularly relevant in procedures involving the introduction of embolization coils.
Evidence Summary
The available literature includes 5 studies, encompassing various study types such as RCTs and case series. These studies span from 2020 to 2024, providing insights into the device's clinical applications.
Reported Outcomes
Published studies report that the French 7 Tri-Access Compact Central Vein is effective in facilitating central venous access for embolization procedures. The device has shown reliable performance in clinical settings, with outcomes supporting its use in embolization-coil applications.
Safety Profile
Reported complications include device-related adverse events typical of central venous access procedures, though specific safety data from the provided evidence is limited. Further research is needed to fully characterize the safety profile.
Evidence Limitations
The evidence base is limited by the small number of studies and the lack of detailed safety data. Further research is needed to explore long-term outcomes and potential complications associated with the device.
Frequently Asked Questions
What are the clinical indications for French 7 Tri-Access Compact Central Vein?
The device is indicated for central venous access in embolization procedures, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective central venous access and reliable performance in embolization procedures.
What complications have been reported?
Reported complications include typical adverse events related to central venous access, though specific data is limited.
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.