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catheter introducer
Target Therapeutics
Summary: The catheter introducer by Target Therapeutics is a device used to facilitate the insertion of catheters into the body. It is primarily used in procedures requiring vascular access. Key evidence highlights its role in reducing nasal trauma during pediatric surgeries.
FDA Clearance Information
Pathway
510K
Number
K860958 ↗
Decision Date
April 23, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The catheter introducer was cleared by the FDA via the 510(k) pathway on April 23, 1986. It is manufactured by Target Therapeutics and classified as a Class 2 device under product code DYB.
What It Is
The catheter introducer is a medical device designed to aid in the insertion of catheters into various body cavities or vessels. It is commonly used in procedures that require precise catheter placement, such as vascular access or endoscopic surgeries.
Clinical Applications
Catheter introducers are frequently used in clinical settings for procedures like vascular catheterization, epidural anesthesia, and endoscopic surgeries. They help in minimizing trauma and ensuring accurate catheter placement.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 1991 to 2020, providing a comprehensive view of the device's clinical applications.
Reported Outcomes
Published studies report that catheter introducers can reduce nasal trauma during pediatric endoscopic surgeries and facilitate easier catheter placement in epidural anesthesia. They are also associated with improved asepsis in urethral catheterization.
Safety Profile
Reported complications include potential nasal trauma in pediatric patients if not used carefully. However, the use of a peel-away sheath has been shown to mitigate such risks. No significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up in some studies. Further research is needed to explore the device's efficacy in diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for catheter introducer?
The catheter introducer is indicated for use in procedures requiring catheter placement, such as vascular access, epidural anesthesia, and endoscopic surgeries.
What outcomes have been reported in clinical studies?
Studies have reported reduced nasal trauma in pediatric surgeries and improved catheter placement in epidural anesthesia.
What complications have been reported?
Safety data indicate potential nasal trauma, though the use of a peel-away sheath can reduce this risk.
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.