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interventional medical y adapter w adjust valve
Intec Medical
Summary: The interventional medical y adapter with adjust valve by Intec Medical is a device used in venous stent procedures. It is FDA 510k cleared. Current evidence includes two studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway
510K
Number
K900998 ↗
Decision Date
August 14, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on August 14, 1990, and is manufactured by Intec Medical. It is classified as a Class 2 device under product code DQY.
What It Is
The interventional medical y adapter with adjust valve is designed for use in venous stent procedures. It allows for the control and adjustment of fluid flow during interventional procedures, providing clinicians with precise management of the procedural environment.
Clinical Applications
This device is commonly used in procedures involving venous stents, where precise control of fluid flow is necessary. It is particularly useful in interventional radiology and cardiology settings.
Evidence Summary
The available literature includes two studies, one published in 2025 and another in 2016. These studies explore related methodologies but do not directly address the device's clinical efficacy or safety.
Reported Outcomes
Published studies report no specific outcomes related to the interventional medical y adapter with adjust valve. The available studies focus on methodologies for DNA profiling and chromatin accessibility, which are not directly applicable to the device's clinical use.
Safety Profile
Reported complications include no specific safety data related to the interventional medical y adapter with adjust valve. The studies provided do not address device-related adverse events.
Evidence Limitations
The current evidence lacks direct clinical studies evaluating the efficacy and safety of the interventional medical y adapter with adjust valve. Further research is needed to establish its clinical benefits and potential complications.
Frequently Asked Questions
What are the clinical indications for the interventional medical y adapter with adjust valve?
The clinical indications are primarily related to its use in venous stent procedures, as outlined in FDA documentation.
What outcomes have been reported in clinical studies?
No specific outcomes related to the device have been reported in the provided studies.
What complications have been reported?
No specific complications related to the device have been reported in 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.