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percutaneous catheter introducer kit
Intec Medical
Summary: The percutaneous catheter introducer kit by Intec Medical is used for vascular access in procedures like embolization. Key evidence highlights its efficacy in reducing procedure time and complication rates.
FDA Clearance Information
Pathway
510K
Number
K903906 ↗
Decision Date
September 26, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous catheter introducer kit by Intec Medical was cleared by the FDA via the 510(k) pathway on September 26, 1990. It is classified as a Class 2 device under product code DYB.
What It Is
The percutaneous catheter introducer kit is designed to facilitate vascular access for procedures such as embolization. It allows for the introduction of catheters into the vascular system through a percutaneous approach.
Clinical Applications
Commonly used in scenarios requiring vascular access, such as embolization procedures, the kit is essential for interventions that involve catheter placement in the vascular system.
Evidence Summary
The literature includes 9 studies, ranging from randomized controlled trials to retrospective analyses, published between 2002 and 2025. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the use of the percutaneous catheter introducer kit can reduce procedure time and complication rates compared to standard techniques. Specifically, modified techniques using this kit have shown lower serum CRP levels and reduced kinking and sheath damage.
Safety Profile
Reported complications include kinking and small damage to the sheath introducer, with modified techniques showing a reduction in these events. Overall, the device demonstrates a favorable safety profile in clinical use.
Evidence Limitations
While the available studies provide valuable insights, there are gaps in long-term outcome data and a need for larger, multicenter trials to validate findings. Further research is required to explore the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for percutaneous catheter introducer kit?
The device is indicated for vascular access in procedures such as embolization, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported reduced procedure time and complication rates, with lower serum CRP levels and reduced kinking and sheath damage.
What complications have been reported?
Safety data indicate complications such as kinking and sheath damage, though these are reduced with modified techniques.
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.