đź“Š Evidence-Based Reference
lead introducer sets-eb-s8 eb-s12
Oscor
Summary: Lead introducer sets by Oscor are used for vascular access in embolization procedures. Cleared by FDA under 510k pathway. Studies highlight their role in managing complications during lead placement.
FDA Clearance Information
Pathway
510K
Number
K831751 ↗
Decision Date
October 20, 1983
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The lead introducer sets by Oscor were cleared by the FDA under the 510k pathway on October 20, 1983. They are classified as Class 2 devices under product code DYB.
What It Is
Lead introducer sets are medical devices used to facilitate the insertion of leads into the vascular system, primarily for embolization procedures. They are designed to provide a stable and secure pathway for lead placement.
Clinical Applications
These devices are commonly used in procedures requiring vascular access, such as the placement of embolization coils. They are essential in scenarios where precise lead placement is critical, such as in cardiac or neurovascular interventions.
Evidence Summary
The literature includes 10 studies ranging from case reports to randomized controlled trials. These studies, published between 2024 and 2025, explore various aspects of lead introducer use, including complication management and alternative techniques.
Reported Outcomes
Published studies report that lead introducer sets are effective in facilitating lead placement with minimal complications. They are particularly useful in managing accidental dural punctures and in scenarios requiring alternative lead extraction techniques.
Safety Profile
Reported complications include rare instances of cerebral air embolism following sheath removal and challenges in lead extraction. These highlight the importance of careful technique and monitoring during procedures.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized trials. Further research is needed to establish standardized protocols and to explore long-term outcomes associated with these devices.
Frequently Asked Questions
What are the clinical indications for lead introducer sets?
Lead introducer sets are indicated for use in vascular access procedures, particularly for the placement of embolization coils.
What outcomes have been reported in clinical studies?
Studies report effective lead placement with minimal complications, highlighting their role in managing procedural challenges.
What complications have been reported?
Safety data indicate rare complications such as cerebral air embolism and difficulties in lead extraction.
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.