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modification material change of peel-away sheath
Quinton
Summary: The modification material change of peel-away sheath by Quinton is a Class 2 medical device used in embolization procedures. It was FDA cleared via the 510k pathway in 1987. Current evidence includes 5 studies, though none directly address this device.
FDA Clearance Information
Pathway
510K
Number
K864705 ↗
Decision Date
February 13, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA under the 510k pathway on February 13, 1987. It is manufactured by Quinton and classified as a Class 2 device under product code DYB.
What It Is
The modification material change of peel-away sheath is a medical device designed to facilitate the insertion and removal of catheters during embolization procedures. It is intended for use in clinical settings where precise catheter placement is necessary.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures requiring the insertion of embolization coils. It provides a reliable method for catheter management, reducing the risk of vascular trauma.
Evidence Summary
The available literature includes 5 studies, though none specifically evaluate this device. The studies span various clinical topics, indicating a need for targeted research on the device's efficacy and safety.
Reported Outcomes
Published studies report no direct outcomes related to the modification material change of peel-away sheath. The current evidence does not provide specific efficacy data for this device.
Safety Profile
Reported complications include no specific safety data for the modification material change of peel-away sheath. The absence of targeted studies limits the understanding of potential adverse events.
Evidence Limitations
The evidence base lacks direct studies on the modification material change of peel-away sheath, highlighting a significant gap in efficacy and safety data. Further research is needed to establish comprehensive clinical guidelines.
Frequently Asked Questions
What are the clinical indications for modification material change of peel-away sheath?
The device is indicated for use in embolization procedures, as per FDA documentation.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported for this device in the provided evidence.
What complications have been reported?
The evidence provided does not report specific complications for this device.
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.