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catheter introducer
Angeion
Summary: The catheter introducer by Angeion is a medical device used primarily for facilitating the insertion of catheters. Key evidence highlights its use in reducing nasal trauma during pediatric surgeries.
FDA Clearance Information
Pathway
510K
Number
K871153 ↗
Decision Date
June 24, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The catheter introducer by Angeion was cleared through the FDA 510(k) pathway on June 24, 1987. 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. It is used to ensure smooth and safe catheter placement, minimizing tissue trauma.
Clinical Applications
Commonly used in procedures requiring catheter insertion, such as epidural anesthesia and endoscopic surgeries. It provides a controlled method for catheter placement, reducing the risk of injury.
Evidence Summary
The literature includes 15 studies, ranging from randomized controlled trials to case series, published between 1987 and 2020. These studies explore various applications and safety profiles of catheter introducers.
Reported Outcomes
Published studies report that the catheter introducer is effective in reducing nasal trauma during pediatric endoscopic surgeries. It also facilitates epidural catheter placement in children, improving procedural success rates.
Safety Profile
Reported complications include potential nasal mucosa trauma if not used properly. However, the device is generally considered safe when used as intended, with no significant adverse events reported 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 its efficacy in diverse clinical settings and patient populations.
Frequently Asked Questions
What are the clinical indications for catheter introducer?
The catheter introducer is indicated for use in procedures requiring catheter insertion, such as epidural anesthesia and endoscopic surgeries.
What outcomes have been reported in clinical studies?
Studies report reduced nasal trauma during pediatric surgeries and improved success rates in epidural catheter placement.
What complications have been reported?
Safety data indicate potential nasal mucosa trauma, but no significant adverse events have been reported when used correctly.
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.