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peel-away introducer set
Cook
Summary: The peel-away introducer set by Cook is a medical device used for the insertion of catheters and other devices into the body. It is primarily used in procedures requiring vascular access. Key evidence highlights its utility in reducing trauma during insertion.
FDA Clearance Information
Pathway
510K
Number
K170020 ↗
Decision Date
September 28, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The peel-away introducer set was cleared by the FDA through the 510(k) pathway on September 28, 2017. It is manufactured by Cook and classified as a Class 2 device under product code DYB.
What It Is
The peel-away introducer set is designed to facilitate the insertion of catheters and other medical devices into the body with minimal trauma. It features a sheath that can be peeled away once the device is in place, allowing for easy removal without disturbing the inserted device.
Clinical Applications
Commonly used in vascular procedures, the peel-away introducer set is employed in scenarios requiring the insertion of central venous catheters, ureteral stents, and other devices. It is particularly useful in procedures where minimizing tissue trauma is critical.
Evidence Summary
The available literature includes four studies, ranging from 1987 to 2013, encompassing various clinical applications of the peel-away introducer sheath. These studies include case series and retrospective analyses, providing insights into its efficacy and safety.
Reported Outcomes
Published studies report that the peel-away introducer sheath is effective in facilitating the insertion of devices with reduced trauma. It has been shown to be useful in both antegrade and retrograde procedures, with applications in vascular and urological interventions.
Safety Profile
Reported complications include minimal trauma during insertion and the potential for device dislodgement. However, the studies highlight the device's overall safety profile when used as intended.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and comparative effectiveness with other introducer systems.
Frequently Asked Questions
What are the clinical indications for the peel-away introducer set?
The peel-away introducer set is indicated for use in procedures requiring the insertion of catheters and other devices into the vascular system or urinary tract, particularly where minimizing tissue trauma is desired.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective device insertion with reduced trauma and successful application in both vascular and urological procedures.
What complications have been reported?
Safety data from evidence indicate minimal trauma during insertion and potential device dislodgement as reported complications.
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.