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flowguide fg60f guidionshort gs60f
Imds Operations
Summary: The flowguide fg60f guidionshort gs60f is a venous stent device used primarily for venous interventions. Key evidence includes studies on embolization materials and long-term hemodynamic changes.
FDA Clearance Information
Pathway
510K
Number
K242337 ↗
Decision Date
April 17, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The flowguide fg60f guidionshort gs60f was cleared through the FDA 510k pathway on April 17, 2025. It is manufactured by Imds Operations and classified as a Class 2 device.
What It Is
The flowguide fg60f guidionshort gs60f is a venous stent designed for use in venous interventions. It is intended to support venous structures and improve blood flow in patients with venous obstructions.
Clinical Applications
This device is commonly used in clinical scenarios involving venous stenting, particularly in cases of venous insufficiency or obstruction. It provides structural support to compromised venous pathways.
Evidence Summary
The available literature includes three studies: a retrospective study from 2024, a case series from 2023, and an older study from 2000. These studies explore embolization materials and hemodynamic changes.
Reported Outcomes
Published studies report varied outcomes related to embolization materials and long-term hemodynamic changes. However, specific efficacy data for the flowguide fg60f guidionshort gs60f is not detailed in the provided studies.
Safety Profile
Reported complications include general risks associated with embolization materials and long-term vascular changes. Specific safety data for the flowguide fg60f guidionshort gs60f is not detailed in the provided studies.
Evidence Limitations
The evidence lacks direct studies on the flowguide fg60f guidionshort gs60f, focusing instead on related embolization techniques and conditions. Further research is needed to evaluate the device's specific efficacy and safety.
Frequently Asked Questions
What are the clinical indications for flowguide fg60f guidionshort gs60f?
The device is indicated for use in venous stenting procedures, particularly in cases of venous obstruction or insufficiency.
What outcomes have been reported in clinical studies?
The studies provided discuss outcomes related to embolization materials and hemodynamic changes, but specific outcomes for the device are not detailed.
What complications have been reported?
Safety data from the studies mention complications related to embolization materials and vascular changes, but specific complications for the device are not detailed.
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.