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catheter introducer
Boston Scientific
Summary: The catheter introducer by Boston Scientific 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 utility in reducing trauma during catheter placement.
FDA Clearance Information
Pathway
510K
Number
K920528 ↗
Decision Date
August 12, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The catheter introducer by Boston Scientific was cleared by the FDA through the 510(k) pathway on August 12, 1992. It is 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 the body, particularly in vascular procedures. It provides a pathway for catheters, minimizing trauma and facilitating smoother insertion.
Clinical Applications
Commonly used in procedures requiring vascular access, the catheter introducer is employed in settings such as endoscopic surgeries and epidural anesthesia. It is particularly useful in pediatric cases where anatomical challenges exist.
Evidence Summary
The literature includes 15 studies, ranging from randomized controlled trials to case series, published between 1991 and 2020. These studies explore various applications and outcomes of the catheter introducer.
Reported Outcomes
Published studies report that the catheter introducer is effective in reducing trauma during catheter placement, particularly in pediatric endoscopic surgeries. It has been shown to facilitate easier catheter insertion in challenging anatomical conditions.
Safety Profile
Reported complications include potential nasal trauma during pediatric procedures, although the introducer is designed to minimize such risks. No significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to establish standardized protocols and to explore long-term outcomes associated with the use of catheter introducers.
Frequently Asked Questions
What are the clinical indications for catheter introducer?
The catheter introducer is indicated for use in procedures requiring vascular access, such as endoscopic surgeries and epidural anesthesia.
What outcomes have been reported in clinical studies?
Studies report reduced trauma during catheter placement and improved ease of insertion in challenging anatomical conditions.
What complications have been reported?
Reported complications include potential nasal trauma, although the device is designed to minimize such risks.
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.