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arterial canalization device
Alimed
Summary: The arterial canalization device by Alimed is used for vascular access in clinical settings. It is FDA-cleared and supported by 10 studies, focusing on its application in venous-stents.
FDA Clearance Information
Pathway
510K
Number
K820516 ↗
Decision Date
April 15, 1982
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The arterial canalization device by Alimed was cleared via the FDA 510k pathway on April 15, 1982. It is classified as a Class 2 device under product code DQY.
What It Is
The arterial canalization device is designed for vascular access, allowing for the insertion of catheters or other instruments into the arterial system. It is primarily used in procedures requiring arterial access.
Clinical Applications
Commonly used in procedures requiring arterial access, such as angiography or the placement of venous stents. It provides a reliable method for accessing the arterial system in various clinical scenarios.
Evidence Summary
The literature includes 10 studies, ranging from 2012 to 2022, with various study types including RCTs and retrospective analyses. These studies explore the device's efficacy and safety in clinical applications.
Reported Outcomes
Published studies report varied outcomes, with some focusing on the efficacy of endovascular procedures and others on novel methods for vascular access. Overall, the device is shown to be effective in facilitating arterial access.
Safety Profile
Reported complications include potential iatrogenic injuries during insertion and issues related to vascular access. However, specific adverse events are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of detailed safety outcomes and specific efficacy metrics. Further research is needed to establish comprehensive safety profiles and long-term efficacy.
Frequently Asked Questions
What are the clinical indications for arterial canalization device?
The device is indicated for use in procedures requiring arterial access, such as angiography and venous stent placement.
What outcomes have been reported in clinical studies?
Studies report effective arterial access facilitation, with varied outcomes depending on the specific clinical application.
What complications have been reported?
Reported complications include potential iatrogenic injuries during insertion, though specific adverse events are not detailed.
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.