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locator model 4036
Pacesetter
Summary: The locator model 4036 by Pacesetter is an IVC filter cleared by the FDA for use in preventing pulmonary embolism. Key evidence includes 10 studies examining its clinical applications.
FDA Clearance Information
Pathway
510K
Number
K972814 ↗
Decision Date
February 23, 1998
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The locator model 4036 was cleared by the FDA through the 510(k) pathway on February 23, 1998. It is manufactured by Pacesetter and classified as a Class 3 medical device.
What It Is
The locator model 4036 is an inferior vena cava (IVC) filter designed to prevent pulmonary embolism by capturing blood clots. It is intended for use in patients at risk of thromboembolic events.
Clinical Applications
Commonly used in patients who are at high risk for pulmonary embolism and cannot undergo anticoagulation therapy. It is placed in the inferior vena cava to intercept clots traveling from the lower extremities.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses. These studies span from 2024 to 2025.
Reported Outcomes
Published studies report on the effectiveness of the locator model 4036 in reducing the incidence of pulmonary embolism. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include device migration and potential for thrombosis at the filter site. Detailed safety data is limited in the provided evidence.
Evidence Limitations
The evidence lacks detailed efficacy metrics and comprehensive safety profiles. Further research is needed to establish long-term outcomes and comparative effectiveness.
Frequently Asked Questions
What are the clinical indications for locator model 4036?
The device is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report a reduction in pulmonary embolism incidence, though specific metrics are not provided.
What complications have been reported?
Safety data indicates potential for device migration and thrombosis at the filter site.
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.