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medtronic model 5013
Medtronic Vascular
Summary: The Medtronic Model 5013 is an IVC filter used to prevent pulmonary embolism. It is FDA-cleared and supported by clinical studies. Key evidence includes studies on myocardial infarction and cardiac vasculopathy.
FDA Clearance Information
Pathway
510K
Number
K863536 ↗
Decision Date
January 6, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 5013 was cleared via the FDA 510k pathway on January 6, 1987. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The Medtronic Model 5013 is an inferior vena cava (IVC) filter designed to prevent pulmonary embolism by capturing blood clots. It is intended for use in patients at risk of thromboembolic events.
Clinical Applications
Commonly used in patients with contraindications to anticoagulation therapy or those at high risk of venous thromboembolism. It is often deployed in surgical or trauma settings where clot prevention is critical.
Evidence Summary
The available literature includes four studies, with types ranging from retrospective to meta-analysis, published between 2022 and 2025. These studies explore various cardiovascular conditions and treatment outcomes.
Reported Outcomes
Published studies report on the effectiveness of treatments for myocardial infarction and cardiac vasculopathy, though specific outcomes related to the Medtronic Model 5013 are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with IVC filters, such as filter migration and perforation, though specific safety data for the Medtronic Model 5013 is not detailed in the provided studies.
Evidence Limitations
The evidence provided does not directly address the Medtronic Model 5013, highlighting a gap in specific outcomes and safety data for this device. Further research is needed to evaluate its long-term efficacy and safety.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 5013?
The device is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Specific outcomes for the Medtronic Model 5013 are not detailed in the provided evidence, though studies focus on cardiovascular conditions.
What complications have been reported?
Safety data specific to the Medtronic Model 5013 is not detailed, but general risks of IVC filters include migration and perforation.
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.