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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 ?
510(k)
Number ?
K241611 ↗
Decision Date ?
September 3, 2024
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- A percutaneous catheter device classified under FDA product code DQY.
- The FDA record provided lists a summary indication but does not include specific anatomic, procedural, or disease indications.
Clinical Applications
- Use in percutaneous catheter-based procedures when selected by the treating physician.
- Use in interventional procedures consistent with the device's complete FDA-cleared labeling and instructions for use.
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.
Practical Considerations
- Confirm the complete FDA clearance letter, labeling, and instructions for use before assigning a specific procedure or anatomy.
- The available record does not establish device dimensions, delivery-system compatibility, access requirements, or deployment technique.
- MRI safety and conditional-use requirements are not provided in the available record; verify them in the manufacturer’s labeling.
- Contraindications, warnings, and precautions should be taken directly from the current instructions for use.
- Do not infer that the device is a venous stent solely from the existing page text or product-code description.
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.