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medtronic model 6971
Medtronic Vascular
Summary: The Medtronic Model 6971 is an IVC filter manufactured by Medtronic Vascular, cleared by the FDA via the 510k pathway. It is primarily used in preventing pulmonary embolism in patients with contraindications to anticoagulation.
FDA Clearance Information
Pathway
510K
Number
K790074 ↗
Decision Date
March 29, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 6971 was cleared by the FDA through the 510k pathway on March 29, 1979. It is manufactured by Medtronic Vascular and classified as a Class 3 medical device.
What It Is
The Medtronic Model 6971 is an inferior vena cava (IVC) filter designed to prevent pulmonary embolism by capturing emboli. It is intended for use in patients who cannot undergo anticoagulation therapy.
Clinical Applications
This device is commonly used in clinical scenarios where patients are at high risk for pulmonary embolism but have contraindications to anticoagulant medications. It provides a mechanical barrier to emboli traveling to the lungs.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. The studies span from 2022 to 2025.
Reported Outcomes
Published studies report varied outcomes related to the use of IVC filters, including effective prevention of pulmonary embolism in high-risk patients. However, specific outcomes related to the Medtronic Model 6971 are not detailed in the provided evidence.
Safety Profile
Reported complications include device-related issues such as premature battery depletion and inappropriate shocks in related devices. Specific safety data for the Medtronic Model 6971 is not detailed in the provided evidence.
Evidence Limitations
The evidence lacks specific data on the Medtronic Model 6971, with most studies focusing on related devices. Further research is needed to establish comprehensive safety and efficacy profiles for this specific model.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 6971?
The device is 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 Model 6971 are not detailed, but IVC filters generally prevent pulmonary embolism in high-risk patients.
What complications have been reported?
Safety data specific to the Medtronic Model 6971 is not provided, but related devices report issues like premature battery depletion and inappropriate shocks.
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.