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wedge tip small model 030-194
Med Telectronics
Summary: The wedge tip small model 030-194 by Med Telectronics is an IVC filter device cleared by the FDA. It is primarily used in clinical settings for preventing pulmonary embolism. Key evidence includes studies on its design and application.
FDA Clearance Information
Pathway
510K
Number
K770283 ↗
Decision Date
February 24, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The wedge tip small model 030-194 was cleared through the FDA 510k pathway on February 24, 1977. Manufactured by Med Telectronics, it is classified as a Class 3 device.
What It Is
The wedge tip small model 030-194 is an IVC filter designed to prevent pulmonary embolism by capturing blood clots. It is used in patients at risk of thromboembolic events.
Clinical Applications
This device is commonly used in patients who are at risk of developing pulmonary embolism, particularly when anticoagulation therapy is contraindicated or ineffective.
Evidence Summary
The available literature includes 8 studies, encompassing various study types such as RCTs and case series. These studies range from 2009 to 2021.
Reported Outcomes
Published studies report on the design and efficacy of the wedge tip small model 030-194 in preventing embolic events. However, specific efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include general device-related issues, but specific safety data is not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the wedge tip small model 030-194. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for wedge tip small model 030-194?
The device is indicated for use in patients at risk of pulmonary embolism, particularly when anticoagulation is not suitable.
What outcomes have been reported in clinical studies?
Specific efficacy outcomes are not detailed in the provided evidence.
What complications have been reported?
Safety data specific to this device is not detailed in the provided evidence.
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.