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lead introducer set various models and sizes
Pace Medical
Summary: The lead introducer set by Pace Medical is a device used for facilitating the insertion of pacing leads. It is FDA 510k cleared and linked to studies evaluating novel pacing approaches and related procedures.
FDA Clearance Information
Pathway
510K
Number
K931662 ↗
Decision Date
August 31, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The lead introducer set by Pace Medical was cleared through the FDA 510k pathway on August 31, 1993. It is classified as a Class 2 device under product code DYB.
What It Is
The lead introducer set is designed to assist in the placement of pacing leads into the heart. It is used in procedures requiring precise lead positioning, often in cardiac pacing interventions.
Clinical Applications
This device is commonly used in scenarios requiring the introduction of pacing leads, such as in patients needing cardiac resynchronization therapy or other pacing interventions. It provides a conduit for safe and accurate lead placement.
Evidence Summary
The literature includes three studies, with types ranging from RCTs to validation studies, published between 2024 and 2026. These studies explore novel pacing techniques and related procedural tools.
Reported Outcomes
Published studies report on the feasibility and safety of echocardiography-guided pacing approaches and the use of introducer needles in laser thermotherapy. However, specific outcomes related to the lead introducer set itself are not detailed.
Safety Profile
Reported complications include challenges with venous access and potential lead-related issues in transvenous procedures. Specific safety data for the lead introducer set is not explicitly detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of direct studies on the lead introducer set itself, with available research focusing on related procedures. Further research is needed to evaluate specific outcomes and safety profiles of this device.
Frequently Asked Questions
What are the clinical indications for lead introducer set?
The lead introducer set is indicated for use in procedures requiring the insertion of pacing leads, such as cardiac resynchronization therapy.
What outcomes have been reported in clinical studies?
Studies have reported on the feasibility of novel pacing techniques and procedural tools, but specific outcomes for the lead introducer set are not detailed.
What complications have been reported?
Reported complications include challenges with venous access and lead-related issues, though specific data for the lead introducer set is not provided.
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.