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peel-away introducer set
Cook
Summary: The peel-away introducer set by Cook is a medical device used primarily for the insertion of catheters and other devices into the body. Key evidence highlights its utility in reducing trauma during procedures.
FDA Clearance Information
Pathway
510K
Number
K173685 ↗
Decision Date
December 20, 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 December 20, 2017. It is manufactured by Cook and classified as a Class 2 device.
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 is commonly used in procedures requiring vascular access.
Clinical Applications
This device is frequently used in scenarios such as the insertion of central venous catheters and ureteral stents. It provides a practical solution for accessing the vascular system or urinary tract with reduced risk of tissue damage.
Evidence Summary
The literature includes four studies, ranging from 1987 to 2013, covering various applications of the peel-away introducer sheath. These studies include case series and retrospective analyses.
Reported Outcomes
Published studies report that the peel-away introducer set is effective in facilitating the insertion of catheters and stents with minimal trauma. It has been shown to be useful in both antegrade and retrograde procedures, enhancing procedural efficiency and patient outcomes.
Safety Profile
Reported complications include minimal trauma during insertion and reduced risk of infection compared to traditional methods. The device is generally considered safe when used as intended.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to confirm long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for peel-away introducer set?
The device is indicated for use in the insertion of catheters and stents, particularly in vascular and urinary tract procedures.
What outcomes have been reported in clinical studies?
Studies report effective insertion with minimal trauma and reduced infection risk.
What complications have been reported?
Safety data indicate minimal trauma and reduced infection risk as primary outcomes.
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.