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modified flowgate balloon guide catheter
Concentric Medical
Summary: The modified flowgate balloon guide catheter by Concentric Medical is used in endovascular stroke interventions. It is FDA 510k cleared. Key evidence includes its application in ischemic stroke treatment.
FDA Clearance Information
Pathway
510K
Number
K131492 ↗
Decision Date
October 3, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The modified flowgate balloon guide catheter was cleared by the FDA through the 510k pathway on October 3, 2013. It is manufactured by Concentric Medical and classified as a Class 2 device.
What It Is
The modified flowgate balloon guide catheter is a medical device used in endovascular procedures, specifically designed to assist in the treatment of ischemic strokes. It functions by providing a pathway for other devices and facilitating blood flow management during interventions.
Clinical Applications
This device is commonly used in the context of ischemic stroke interventions, where it aids in the navigation and deployment of therapeutic devices. It is particularly useful in scenarios requiring precise control of blood flow.
Evidence Summary
The available literature includes two studies: one published in 2020 and another with an unknown date. These studies explore the use of the device in stroke interventions, focusing on its application and outcomes.
Reported Outcomes
Published studies report the use of the FlowGate2 as a balloon guide catheter in endovascular stroke intervention, highlighting its effectiveness in facilitating the procedure. However, specific efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include typical procedural risks associated with endovascular interventions, but specific adverse events related to the device are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for modified flowgate balloon guide catheter?
The device is indicated for use in endovascular procedures, particularly in the treatment of ischemic strokes.
What outcomes have been reported in clinical studies?
Studies report its use in stroke interventions, but specific efficacy outcomes are not detailed.
What complications have been reported?
While typical procedural risks are noted, specific complications related to the device are not detailed in the evidence provided.
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.