📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for thromboembolic disease.
- Use when anticoagulant therapy is contraindicated or ineffective.
Clinical Applications
- Placement in the inferior vena cava to reduce the risk of pulmonary embolism.
- Protection from emboli in patients with thromboembolic disease who cannot receive anticoagulation.
- Protection from pulmonary embolism when anticoagulation has not adequately prevented thromboembolic events.
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.
Practical Considerations
- The record identifies this device as the small model 030-194; additional size, delivery-system, and compatibility details should be confirmed in the original labeling.
- Placement requires imaging guidance and assessment of the inferior vena cava and access veins before deployment.
- The record does not establish MRI safety; MRI conditions should be confirmed from the original manufacturer labeling or FDA documentation before scanning.
- Potential complications of IVC filters include malposition, migration, vena cava perforation, filter thrombosis, and recurrent pulmonary embolism.
- The treating clinician should assess whether anticoagulation, filter placement, or another treatment is appropriate and should follow the device labeling for contraindications and follow-up.
Procedures that use this device
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.