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introdeuce double lumen introducer
Cook
Summary: The introdeuce double lumen introducer by Cook is a device used primarily for vascular access and embolization procedures. Key evidence highlights its application in complex intubations and ECMO cannulation.
FDA Clearance Information
Pathway
510K
Number
K001985 ↗
Decision Date
January 25, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introdeuce double lumen introducer was cleared by the FDA via the 510(k) pathway on January 25, 2001. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The introdeuce double lumen introducer is a medical device designed for facilitating vascular access, particularly in procedures requiring embolization coils. It allows for the introduction of catheters or other devices into the vascular system.
Clinical Applications
Commonly used in procedures requiring precise vascular access, such as embolization and ECMO cannulation. It is particularly useful in complex intubations where traditional methods may be challenging.
Evidence Summary
The available literature includes 9 studies, ranging from case reports to retrospective analyses, published between 2012 and 2021. These studies explore various clinical applications and outcomes of the device.
Reported Outcomes
Published studies report successful use of the device in complex intubations and ECMO cannulation. The device has been shown to facilitate accurate placement of double lumen tubes and cannulas, improving procedural success rates.
Safety Profile
Reported complications include malposition of guide wires and challenges in visualization during placement. These issues highlight the need for careful technique and adjunctive imaging methods.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials. Most studies are case reports or small series, which may not fully capture the device's efficacy and safety profile. Further research is needed to establish standardized protocols and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for introdeuce double lumen introducer?
The device is indicated for vascular access in procedures requiring embolization coils and complex intubations, such as ECMO cannulation.
What outcomes have been reported in clinical studies?
Studies have reported successful placement of double lumen tubes and cannulas, with improved procedural success in complex cases.
What complications have been reported?
Safety data indicate complications such as guide wire malposition and visualization challenges during placement.
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.