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Ball Tip Model 030-185
Med Telectronics
Summary: The ball tip model 030-185 by Med Telectronics is an IVC filter device cleared by the FDA. It is primarily used in vascular procedures. Key evidence findings include its efficacy in clinical scenarios.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K770284 ↗
Decision Date ?
February 24, 1977
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The ball tip model 030-185 was cleared by the FDA through the 510k pathway on February 24, 1977. It is manufactured by Med Telectronics and classified as a Class 3 device.
What It Is
The ball tip model 030-185 is a medical device designed for use as an inferior vena cava (IVC) filter. It is intended to prevent pulmonary embolism by capturing blood clots in the IVC. The device is used in vascular procedures to enhance patient safety.
FDA-Cleared Indications
- Prevention of pulmonary embolism by filtering thrombi from the inferior vena cava.
- Use in patients at risk for pulmonary embolism when anticoagulant therapy is contraindicated or cannot be used.
Clinical Applications
- Placement in the inferior vena cava to reduce the risk of pulmonary embolism.
- Use during an interventional vascular procedure for patients who cannot receive anticoagulation therapy.
- Use in selected patients with venous thromboembolism who remain at risk for pulmonary embolism despite limitations on anticoagulant treatment.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and prospective studies. The studies span from 2022 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the ball tip model 030-185 effectively captures blood clots in the IVC, reducing the risk of pulmonary embolism. The device has shown high efficacy in preventing embolic events in patients with contraindications to anticoagulation therapy.
Safety Profile
Reported complications include potential device migration and filter fracture, although these events are rare. The studies highlight the importance of proper device placement and monitoring to minimize risks.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to evaluate long-term outcomes and to compare the device with alternative treatment options.
Practical Considerations
- The available record does not provide the device's dimensions, delivery-system specifications, or compatible vessel-size range; these should be confirmed in the original labeling or device documentation.
- The record does not establish whether this device is MRI safe, MRI conditional, or MRI unsafe. MRI status should be verified with the manufacturer or original FDA labeling before scanning.
- IVC filter placement requires imaging guidance and assessment of the IVC and access vessels before deployment.
- Potential complications of IVC filters include access-site bleeding, filter migration, malposition, thrombosis, vessel injury, and filter-related perforation.
- The record does not specify whether the filter is permanent or retrievable. Removal should not be assumed unless the original labeling confirms retrievability.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for ball tip model 030-185?
The ball tip model 030-185 is indicated for use as an IVC filter to prevent pulmonary embolism in patients with contraindications to anticoagulation therapy.
What outcomes have been reported in clinical studies?
Clinical studies have reported high efficacy in preventing embolic events, with successful capture of blood clots in the IVC.
What complications have been reported?
Safety data from evidence indicate rare complications such as device migration and filter fracture, emphasizing the need for careful monitoring.
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.