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medtronic models 4012 4512
Medtronic Vascular
Summary: Medtronic models 4012 and 4512 are IVC filters designed to prevent pulmonary embolism. Cleared by FDA via 510k pathway. Evidence includes 10 studies with varied focus.
FDA Clearance Information
Pathway
510K
Number
K832099 ↗
Decision Date
July 26, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic models 4012 and 4512 were cleared by the FDA through the 510k pathway on July 26, 1983. Manufactured by Medtronic Vascular, these devices are classified as Class 3 under product code DTB.
What It Is
The Medtronic models 4012 and 4512 are inferior vena cava (IVC) filters used to prevent pulmonary embolism by capturing blood clots. They are intended for use in patients at risk of thromboembolic events.
Clinical Applications
These IVC filters are commonly used in patients who cannot undergo anticoagulation therapy or have recurrent thromboembolic events despite anticoagulation. They provide a mechanical barrier to prevent clots from reaching the lungs.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and modeling studies, published between 2022 and 2025. These studies explore diverse applications of AI in medical procedures.
Reported Outcomes
Published studies report advancements in AI applications for medical procedures, including improved detection of colorectal polyps and enhanced surgical skill assessments. However, specific outcomes related to Medtronic models 4012 and 4512 are not detailed in the provided evidence.
Safety Profile
Reported complications include the general risks associated with IVC filters, such as filter migration and perforation. However, specific safety data for Medtronic models 4012 and 4512 are not detailed in the provided evidence.
Evidence Limitations
The evidence provided does not directly address the efficacy or safety of Medtronic models 4012 and 4512. Further research is needed to evaluate specific outcomes and complications associated with these devices.
Frequently Asked Questions
What are the clinical indications for Medtronic models 4012 and 4512?
The clinical indications include prevention of pulmonary embolism in patients at risk of thromboembolic events, particularly when anticoagulation is contraindicated.
What outcomes have been reported in clinical studies?
The provided studies focus on AI applications in medical procedures, with no specific outcomes reported for Medtronic models 4012 and 4512.
What complications have been reported?
Reported complications include general risks of IVC filters, such as migration and perforation, though specific data for these models 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.