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subclavian introducer set
Infusaid
Summary: The subclavian introducer set by Infusaid is a medical device used for vascular access, primarily in central venous catheterization. Key evidence highlights its efficacy in facilitating catheter placement with minimal complications.
FDA Clearance Information
Pathway
510K
Number
K902251 ↗
Decision Date
July 31, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The subclavian introducer set was cleared by the FDA through the 510(k) pathway on July 31, 1990. It is manufactured by Infusaid and classified as a Class 2 device.
What It Is
The subclavian introducer set is designed to facilitate the insertion of catheters into the subclavian vein. It is used in clinical settings for procedures requiring central venous access, such as the placement of pacemaker leads or long-term central venous catheters.
Clinical Applications
Commonly used in scenarios requiring central venous access, the subclavian introducer set is employed in the placement of pacemaker and defibrillator leads, as well as in the insertion of catheters for hemodynamic studies and ventriculovenous shunts.
Evidence Summary
The literature includes six studies ranging from 1983 to 1999, encompassing various study types such as RCTs and case series. These studies evaluate the device's efficacy and safety in different clinical applications.
Reported Outcomes
Published studies report high success rates in lead placement using the subclavian introducer set, with a noted overall success rate of 49 cases in one study. The device is associated with shorter lead placement times and fewer contrast injections when using the medial approach.
Safety Profile
Reported complications include a low incidence of major complications, with one study specifically noting no major complications during the use of the subclavian introducer set for lead placement.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to evaluate long-term outcomes and to compare the efficacy of the subclavian introducer set with alternative devices.
Frequently Asked Questions
What are the clinical indications for subclavian introducer set?
The subclavian introducer set is indicated for 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?
Clinical studies have reported high success rates in catheter and lead placement, with shorter procedure times and fewer complications using the medial approach.
What complications have been reported?
Safety data from studies indicate a low incidence of major complications, with some studies reporting no major complications during the use of the device.
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.