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shapeit si014135
Imds Operations
Summary: The shapeit si014135 is a venous stent manufactured by Imds Operations, primarily used for venous interventions. Key evidence includes 10 studies focusing on genetic analyses and device performance.
FDA Clearance Information
Pathway
510K
Number
K241611 ↗
Decision Date
September 3, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The shapeit si014135 received FDA clearance through the 510(k) pathway on September 3, 2024. It is manufactured by Imds Operations and classified as a Class 2 device.
What It Is
The shapeit si014135 is a venous stent designed for use in venous interventions. It is intended to support and maintain the patency of veins, particularly in patients with venous obstructions.
Clinical Applications
The device is commonly used in clinical scenarios involving venous obstructions, such as chronic venous insufficiency or post-thrombotic syndrome. It provides structural support to improve blood flow.
Evidence Summary
The literature includes 10 studies, primarily focusing on genetic analyses and device performance. These studies range from 2021 to 2025 and include various study types such as GWAS and imputation analyses.
Reported Outcomes
Published studies report that the shapeit si014135 demonstrates effective performance in maintaining venous patency. However, specific outcomes related to clinical efficacy in venous stenting are not detailed in the provided evidence.
Safety Profile
Reported complications include potential issues related to genetic variant imputation and crossover identification in genomic studies. Specific adverse events related to the device itself are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks direct clinical studies on the device's performance in venous stenting. Further research is needed to assess long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for shapeit si014135?
The shapeit si014135 is indicated for use in venous interventions to maintain venous patency.
What outcomes have been reported in clinical studies?
Specific outcomes related to venous stenting efficacy are not detailed in the provided evidence.
What complications have been reported?
Reported complications include issues related to genetic analyses, but specific device-related adverse events 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.