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medtronic models 4011 4511
Medtronic Vascular
Summary: The Medtronic Models 4011 and 4511 are IVC filters manufactured by Medtronic Vascular, cleared by the FDA through the 510(k) pathway. They are primarily used for preventing pulmonary embolism in patients with contraindications to anticoagulation.
FDA Clearance Information
Pathway
510K
Number
K822781 ↗
Decision Date
November 30, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Models 4011 and 4511 received FDA clearance through the 510(k) pathway on November 30, 1982. They are manufactured by Medtronic Vascular and classified as Class III devices.
What It Is
The Medtronic Models 4011 and 4511 are inferior vena cava (IVC) filters designed to prevent pulmonary embolism by capturing emboli. They are intended for use in patients who have contraindications to anticoagulation therapy.
Clinical Applications
These IVC filters are commonly used in clinical scenarios where patients are at risk of pulmonary embolism but cannot undergo anticoagulation therapy. They are often employed in trauma patients, those with active bleeding, or those undergoing surgery.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and modeling studies, with publication years ranging from 2022 to 2025. These studies explore the integration of AI in clinical settings and surgical skill assessments.
Reported Outcomes
Published studies report advancements in AI applications for surgical skill assessment and colorectal cancer screening, though specific outcomes related to the Medtronic Models 4011 and 4511 are not detailed in the provided evidence.
Safety Profile
Reported complications include the general risks associated with IVC filter placement, such as filter migration, fracture, and thrombosis. However, specific safety data for these models are not detailed in the provided evidence.
Evidence Limitations
The evidence provided does not directly address the clinical outcomes or safety of the Medtronic Models 4011 and 4511. Further research is needed to evaluate their long-term efficacy and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Medtronic Models 4011 4511?
The devices are indicated for preventing pulmonary embolism in patients with contraindications to anticoagulation therapy.
What outcomes have been reported in clinical studies?
Specific outcomes for the Medtronic Models 4011 and 4511 are not detailed in the provided evidence.
What complications have been reported?
Safety data specific to these models are not detailed, but general IVC filter complications include migration, fracture, and thrombosis.
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.