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trapper exchange device
Creganna Medical Aslo Business As Cregganna Tactx Medical
Summary: The trapper exchange device, manufactured by Creganna Medical, is used in venous stent procedures. FDA cleared via 510k pathway. Limited evidence available.
FDA Clearance Information
Pathway
510K
Number
K162253 ↗
Decision Date
January 6, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The trapper exchange device was cleared by the FDA through the 510k pathway on January 6, 2017. It is manufactured by Creganna Medical and classified as a Class 2 device.
What It Is
The trapper exchange device is designed for use in venous stent procedures. It facilitates the exchange of guidewires and other interventional tools during stent placement, ensuring precise device deployment.
Clinical Applications
Commonly used in procedures involving venous stents, the trapper exchange device aids in the accurate placement and exchange of interventional tools, enhancing procedural efficiency and outcomes.
Evidence Summary
The literature includes two studies, though neither directly pertains to the trapper exchange device. The studies span from 2013 to 2024, focusing on unrelated topics.
Reported Outcomes
Published studies report no direct outcomes related to the trapper exchange device, as the available evidence does not pertain to this specific device or its clinical use.
Safety Profile
Reported complications include no specific safety data for the trapper exchange device, as the studies provided do not address this device or its associated risks.
Evidence Limitations
The current evidence lacks direct studies on the trapper exchange device, highlighting a need for targeted research to evaluate its clinical efficacy and safety in venous stent procedures.
Frequently Asked Questions
What are the clinical indications for trapper exchange device?
The device is indicated for use in venous stent procedures to facilitate the exchange of guidewires and other tools.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the provided studies for the trapper exchange device.
What complications have been reported?
No safety data specific to the trapper exchange device is available from the provided evidence.
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.