📊 Evidence-Based Reference
Catheter Introducer
Luther Medical Products
Summary: The catheter introducer by Luther Medical Products is a device used to facilitate the insertion of catheters. It is primarily used in procedures requiring vascular access. Key evidence highlights its role in reducing trauma during catheter placement.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K924562 ↗
Decision Date ?
February 25, 1993
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The catheter introducer by Luther Medical Products was cleared via the FDA 510(k) pathway on February 25, 1993. 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 stable pathway for catheters, minimizing trauma and improving the ease of catheter placement.
FDA-Cleared Indications
- Facilitation of catheter insertion during vascular access procedures.
- Provision of a stable access pathway for catheter placement.
- Use in procedures where controlled catheter introduction is required.
Clinical Applications
- Obtaining vascular access for diagnostic or interventional catheter procedures.
- Providing access for catheter-based embolization procedures.
- Providing access for transjugular intrahepatic portosystemic shunt procedures.
- Facilitating catheter placement when minimizing trauma during insertion is important.
Evidence Summary
The literature includes 15 studies, with a mix of randomized controlled trials, prospective, and retrospective studies, spanning from 1991 to 2020. These studies explore various applications and outcomes of the catheter introducer.
Reported Outcomes
Published studies report that the catheter introducer effectively reduces trauma during catheter placement, particularly in pediatric and complex anatomical scenarios. It has been shown to facilitate easier catheter insertion and improve procedural outcomes.
Safety Profile
Reported complications include minor trauma to insertion sites and potential for infection if aseptic techniques are not strictly followed. Overall, the device is considered safe when used according to guidelines.
Evidence Limitations
The evidence is limited by the small sample sizes in some studies and the lack of long-term outcome data. Further research is needed to explore its efficacy across diverse patient populations and procedural contexts.
Practical Considerations
- The introducer must be matched to the catheter diameter, access vessel, and intended procedure; available sizes and configurations vary by product.
- Use requires sterile technique and appropriate imaging or procedural guidance, commonly ultrasound and fluoroscopy for vascular procedures.
- The device is generally intended for single-use application unless its specific labeling states otherwise.
- MRI safety depends on the exact introducer materials and model. Confirm MR Safe, MR Conditional, or MR Unsafe status in the product labeling before MRI.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, air embolism, and difficulties with insertion or removal.
Procedures that use this device
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, particularly in pediatric patients.
What outcomes have been reported in clinical studies?
Studies have reported reduced trauma during catheter placement and improved procedural outcomes, especially in challenging anatomical scenarios.
What complications have been reported?
Reported complications include minor trauma at insertion sites and potential infection risks if aseptic techniques are not followed.
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.