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medtronic model 4558m
Medtronic Vascular
Summary: The Medtronic Model 4558m is an IVC filter used to prevent pulmonary embolism. It is FDA 510k cleared and supported by 10 studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K940703 ↗
Decision Date
November 4, 1994
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 4558m was cleared by the FDA via the 510k pathway on November 4, 1994. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The Medtronic Model 4558m 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
This device is commonly used in patients who are at high risk for pulmonary embolism and cannot be managed with anticoagulation therapy. It is typically deployed in the inferior vena cava to intercept emboli.
Evidence Summary
The available literature includes 10 studies, with a range of study types such as RCTs and modeling studies, published between 2022 and 2025. However, specific data on the Medtronic Model 4558m is sparse.
Reported Outcomes
Published studies report limited specific outcomes for the Medtronic Model 4558m. The evidence primarily focuses on the broader category of IVC filters and their role in preventing pulmonary embolism.
Safety Profile
Reported complications include general risks associated with IVC filters, such as filter migration and perforation. Specific safety data for the Medtronic Model 4558m is not detailed in the provided studies.
Evidence Limitations
The evidence for the Medtronic Model 4558m is limited, with a lack of specific outcomes and safety data. Further research is needed to evaluate its long-term efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 4558m?
The device is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Specific outcomes for the Medtronic Model 4558m are not detailed; studies focus on the general efficacy of IVC filters.
What complications have been reported?
Safety data from evidence includes risks like filter migration and perforation, common to IVC filters.
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.