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french percutaneous sheath introducer
Norton Performance Plastics
Summary: The french percutaneous sheath introducer by Norton Performance Plastics is used for vascular access in interventional procedures. Key evidence highlights its feasibility and safety in both cardiac and noncardiac interventions.
FDA Clearance Information
Pathway
510K
Number
K830813 ↗
Decision Date
April 28, 1983
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared via the FDA 510(k) pathway on April 28, 1983. Manufactured by Norton Performance Plastics, it is classified as a Class 2 device under product code DYB.
What It Is
The french percutaneous sheath introducer is a medical device designed to facilitate vascular access during interventional procedures. It is primarily used to introduce catheters and other devices into the vascular system.
Clinical Applications
Commonly used in procedures requiring vascular access, such as percutaneous coronary interventions and embolization procedures. It is suitable for both cardiac and noncardiac interventions.
Evidence Summary
The literature includes 11 studies, encompassing various study types such as RCTs and retrospective analyses, with publication years ranging from 2022 to 2025.
Reported Outcomes
Published studies report that the device is effective in facilitating vascular access for complex coronary lesions and noncardiac interventions. The distal radial access approach has been highlighted for its low invasiveness and feasibility.
Safety Profile
Reported complications include radial artery spasm and occlusion, particularly when larger sheath sizes are used. However, the device is generally considered safe when used appropriately.
Evidence Limitations
Current evidence is limited by a focus on specific access techniques and patient populations. Further research is needed to explore broader applications and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for french percutaneous sheath introducer?
The device is indicated for vascular access in interventional procedures, including percutaneous coronary interventions and embolization.
What outcomes have been reported in clinical studies?
Studies have reported effective vascular access with low invasiveness, particularly using distal radial access techniques.
What complications have been reported?
Safety data indicate potential complications such as radial artery spasm and occlusion, especially with larger sheath sizes.
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.