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coaxial introducer set
Martech Medical Products
Summary: The coaxial introducer set by Martech Medical Products is a device used primarily for vascular access in embolization procedures. Key evidence includes successful use in complex embolization cases.
FDA Clearance Information
Pathway
510K
Number
K101399 ↗
Decision Date
June 17, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The coaxial introducer set was cleared by the FDA via the 510(k) pathway on June 17, 2010. It is manufactured by Martech Medical Products and classified as a Class 2 device.
What It Is
The coaxial introducer set is a medical device designed to facilitate vascular access, particularly in embolization procedures. It consists of a series of coaxial components that allow for precise placement and manipulation within the vascular system.
Clinical Applications
Commonly used in interventional radiology, the coaxial introducer set is employed in procedures such as embolization of endoleaks and other vascular interventions where precise access is critical.
Evidence Summary
The literature includes six studies ranging from 2003 to 2026, covering various applications of the coaxial introducer set. Study types include case series and experimental studies, highlighting its use in complex vascular procedures.
Reported Outcomes
Published studies report successful embolization of type 2 endoleaks using the coaxial introducer set, with effective deployment of embolic agents. The device has also been used in experimental settings for precise needle placement in post-mortem analyses.
Safety Profile
Reported complications include challenges related to venous access and potential lead-related issues in transvenous procedures. However, specific adverse events directly attributed to the coaxial introducer set are not detailed in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for the coaxial introducer set?
The coaxial introducer set is indicated for use in vascular access during embolization procedures, particularly in interventional radiology.
What outcomes have been reported in clinical studies?
Studies report successful embolization of vascular anomalies and effective use in experimental needle placement procedures.
What complications have been reported?
Safety data indicate potential challenges with venous access, but specific complications directly related to the device are not extensively documented.
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.