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dual guide introducer catheter
Cook
Summary: The dual guide introducer catheter by Cook is used primarily in embolization procedures. Key evidence highlights its role in complex interventions requiring dual catheter placement.
FDA Clearance Information
Pathway
510K
Number
K895044 ↗
Decision Date
February 26, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The dual guide introducer catheter was cleared by the FDA through the 510(k) pathway on February 26, 1990. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The dual guide introducer catheter is a medical device designed to facilitate the introduction of guide wires and other devices into the vascular system. It is primarily used in embolization procedures, allowing for precise placement and control during interventions.
Clinical Applications
This device is commonly used in procedures requiring dual catheter placement, such as complex embolization and revascularization interventions. It is particularly useful in scenarios where simultaneous access to multiple vascular sites is needed.
Evidence Summary
The available literature includes four studies, ranging from 2012 to 2021, covering various aspects of catheter use in clinical settings. Study types include RCTs, prospective, retrospective, and case series.
Reported Outcomes
Published studies report the dual guide introducer catheter as effective in facilitating complex vascular interventions, such as coronary chronic total occlusions and aortic coarctation stent placements. The device enables precise catheter placement and improved procedural outcomes.
Safety Profile
Reported complications include challenges in catheter placement in inexperienced hands, as noted in studies focusing on technical advancements. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed outcomes and safety data. Further research is needed to explore long-term efficacy and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for dual guide introducer catheter?
The device is indicated for use in embolization procedures and other interventions requiring dual catheter placement, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of complex vascular interventions, such as coronary chronic total occlusions and aortic coarctation stent placements.
What complications have been reported?
Reported complications include challenges in catheter placement for inexperienced practitioners, with no specific adverse events detailed in the studies.
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.