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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 ?
510(k)
Number ?
K242337 ↗
Decision Date ?
April 17, 2025
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- The FDA record identifies the device as a percutaneous catheter under 21 CFR 870.1250.
- The available FDA summary does not state a specific disease, vessel, or therapeutic indication.
Clinical Applications
- Percutaneous vascular catheter procedures when the device is used according to its FDA-cleared labeling.
- Catheter-based access or delivery during vascular interventions, subject to the complete manufacturer instructions for use.
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.
Practical Considerations
- The available record does not list the catheter's French size, working length, distal configuration, guidewire compatibility, or other dimensional specifications; confirm these in the manufacturer instructions for use.
- Compatibility with guidewires, introducer sheaths, contrast agents, embolic materials, and other devices must be verified before use.
- MRI safety or MR conditional labeling is not established in the supplied record; consult the device labeling before MRI.
- Contraindications, warnings, and handling requirements should be taken from the current manufacturer instructions for use rather than inferred from the product code.
- This device should not be described as a venous stent unless separate documentation confirms that indication and device function.
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.