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wedge tip small model 030-191
Med Telectronics
Summary: The wedge tip small model 030-191 by Med Telectronics is a Class 3 medical device used in clinical settings, primarily for ivc-filters. Key evidence includes studies on its application and safety profile.
FDA Clearance Information
Pathway
510K
Number
K770282 ↗
Decision Date
February 24, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on February 24, 1977. It is manufactured by Med Telectronics and classified as a Class 3 device.
What It Is
The wedge tip small model 030-191 is a medical device designed for use in ivc-filters. It operates by providing a specific mechanical function essential for the intended clinical application.
Clinical Applications
This device is commonly used in procedures involving inferior vena cava filters, providing a critical component for the safe and effective deployment of the filter.
Evidence Summary
The available literature includes 8 studies, with a mix of study types such as RCTs and case series, published between 2009 and 2021. These studies explore various aspects of the device's application.
Reported Outcomes
Published studies report varied outcomes, focusing on the device's efficacy in clinical settings. However, specific efficacy data is not detailed in the provided evidence.
Safety Profile
Reported complications include general device-related issues, but specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the device. Further research is needed to fully understand its efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for wedge tip small model 030-191?
The device is indicated for use in ivc-filters, as per FDA documentation.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the provided evidence.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications detailed.
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.