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peel-away sheath a component of argon introd set
Argon Medical
Summary: The peel-away sheath by Argon Medical is a component of an introducer set used primarily for vascular access procedures. Key evidence highlights its role in reducing mechanical complications during catheter insertion.
FDA Clearance Information
Pathway
510K
Number
K852880 ↗
Decision Date
August 29, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The peel-away sheath was cleared by the FDA through the 510(k) pathway on August 29, 1985. It is manufactured by Argon Medical and classified as a Class 2 device.
What It Is
The peel-away sheath is a medical device used in conjunction with introducer sets to facilitate the insertion of catheters into blood vessels. It is designed to 'peel away' after catheter placement, minimizing trauma to the vessel.
Clinical Applications
Commonly used in procedures requiring vascular access, such as the placement of peripherally inserted central catheters (PICCs) and other central venous catheters. It is particularly useful in reducing mechanical complications during insertion.
Evidence Summary
The literature includes a mix of study types, such as RCTs and case series, with a total of 6 studies ranging from 1994 to 2025. These studies explore various technical and clinical aspects of sheath use.
Reported Outcomes
Published studies report that the peel-away sheath is effective in facilitating catheter placement with reduced mechanical complications. The optimized insertion techniques have shown improved outcomes in terms of procedural success and reduced need for additional interventions.
Safety Profile
Reported complications include mechanical issues such as shearing of the sheath during insertion, which may require further dermatotomy. However, these events are relatively infrequent and manageable with proper technique.
Evidence Limitations
The evidence is limited by the small number of studies specifically focusing on the peel-away sheath. Further research is needed to explore long-term outcomes and compare its efficacy with alternative devices.
Frequently Asked Questions
What are the clinical indications for peel-away sheath?
The peel-away sheath is indicated for use in vascular access procedures, such as the insertion of central venous catheters.
What outcomes have been reported in clinical studies?
Studies have reported effective catheter placement with reduced mechanical complications when using the peel-away sheath.
What complications have been reported?
Safety data indicate mechanical complications like sheath shearing during insertion, though these are infrequent and manageable.
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.