📊 Evidence-Based Reference
Catheter Introducer
Summary: The catheter introducer by Galt Medical is used primarily for facilitating catheter placement in various clinical settings. Key evidence highlights its role in reducing trauma during procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K043525 ↗
Decision Date ?
February 9, 2005
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The catheter introducer by Galt Medical was cleared through the FDA 510(k) pathway on February 9, 2005. It is classified as a Class 2 device under product code DYB.
What It Is
The catheter introducer is a medical device designed to assist in the insertion of catheters into the body. It is used to facilitate catheter placement by providing a stable pathway, minimizing tissue trauma during insertion.
FDA-Cleared Indications
- Used to facilitate the introduction and placement of catheters during medical procedures.
- Intended to provide a pathway for catheter access while helping limit tissue trauma during insertion.
Clinical Applications
- Establishing access for catheter-based vascular procedures.
- Facilitating catheter placement during interventional radiology procedures.
- Providing access for procedures in which a catheter must be advanced through a blood vessel or other body passage.
Evidence Summary
The literature includes 15 studies, comprising RCTs, prospective, and retrospective studies, spanning from 1991 to 2020. These studies explore various clinical applications and outcomes of catheter introducers.
Reported Outcomes
Published studies report that catheter introducers can reduce nasal trauma during pediatric endoscopic surgeries and facilitate epidural catheter placement in children. They also improve asepsis during urethral catheterization.
Safety Profile
Reported complications include potential nasal trauma reduction in pediatric surgeries and improved aseptic techniques in catheterization. However, specific adverse events are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small sample sizes and lack of detailed safety outcomes in some studies. Further research is needed to explore long-term safety and efficacy across diverse patient populations.
Practical Considerations
- Introducers are available in different sizes and configurations; the selected size must match the catheter, guidewire, and target access site.
- Use requires sterile technique and imaging or other appropriate guidance when entering a blood vessel or deep body structure.
- Compatibility with the catheter, guidewire, connector, and any hemostasis valve should be confirmed before use.
- MRI safety depends on the specific introducer materials and whether the device remains in the patient; consult the product labeling and institutional MRI policy.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, air embolism, and damage to the catheter or introducer.
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 catheter placement, such as vascular access, epidural anesthesia, and urethral catheterization.
What outcomes have been reported in clinical studies?
Studies report reduced nasal trauma in pediatric surgeries and improved catheter placement in epidural anesthesia and urethral catheterization.
What complications have been reported?
Reported complications include potential reduction in nasal trauma and improved aseptic techniques, but specific adverse events are not detailed.
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.