📊 Evidence-Based Reference
Subclavian Introducer Set
Infusaid
Summary: The subclavian introducer set by Infusaid is used for vascular access, primarily in central venous catheterization. Key evidence highlights its effectiveness in facilitating catheter placement with minimal complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K860898 ↗
Decision Date ?
April 29, 1986
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The subclavian introducer set was cleared by the FDA via the 510(k) pathway on April 29, 1986. It is manufactured by Infusaid and classified as a Class 2 medical device.
What It Is
The subclavian introducer set is a medical device designed to facilitate the insertion of catheters into the subclavian vein. It is commonly used in procedures requiring central venous access, such as the placement of pacemaker leads or long-term central venous catheters.
FDA-Cleared Indications
- Facilitation of catheter insertion into the subclavian vein for central venous access.
- Use with catheter placement procedures requiring access through the subclavian vein, according to the device labeling.
Clinical Applications
- Establishing subclavian venous access for placement of central venous catheters.
- Facilitating placement of pacemaker leads.
- Facilitating placement of defibrillator leads.
- Obtaining central venous access when a subclavian approach is selected by the treating clinician.
Evidence Summary
The available literature includes six studies, ranging from 1983 to 1999, encompassing various study designs such as RCTs and case series. These studies evaluate the device's efficacy and safety in different clinical settings.
Reported Outcomes
Published studies report that the subclavian introducer set is effective in achieving successful lead placement, with a higher success rate using the medial approach. The device also reduces lead placement time and the number of contrast injections required.
Safety Profile
Reported complications include a low incidence of major complications, with studies noting the absence of significant adverse events. The device is considered safe for use in its intended applications.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of recent studies. Further research is needed to evaluate long-term outcomes and to compare the device with newer technologies.
Practical Considerations
- The available sizes, needle dimensions, dilator configuration and catheter compatibility depend on the specific set and its labeling.
- The device is intended for use by trained clinicians with sterile technique and imaging or other appropriate procedural guidance.
- Subclavian access can cause complications such as arterial puncture, bleeding, infection, pneumothorax, hemothorax, thrombosis or malposition.
- MRI safety depends on the complete system, including any catheter or implanted lead placed through the introducer; the set should not be assumed to be MRI safe without manufacturer-specific information.
- Contraindications and precautions include infection at the access site, uncontrolled bleeding risk, altered anatomy and inability to safely identify or access the subclavian vein.
Frequently Asked Questions
What are the clinical indications for the subclavian introducer set?
The device is indicated for use in procedures requiring central venous access, such as the placement of pacemaker leads and long-term central venous catheters.
What outcomes have been reported in clinical studies?
Studies report high success rates in lead placement, reduced procedure times, and fewer contrast injections with the medial approach.
What complications have been reported?
Safety data indicate a low incidence of major complications, with no significant adverse events reported in the studies reviewed.
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.