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ht model ht pb
Sulzer Oscor
Summary: The ht model ht pb is an IVC filter manufactured by Sulzer Oscor, primarily used for preventing pulmonary embolism. Key evidence includes 11 studies examining various clinical outcomes and safety profiles.
FDA Clearance Information
Pathway
510K
Number
K990142 ↗
Decision Date
July 30, 1999
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The ht model ht pb received FDA clearance through the 510(k) pathway on July 30, 1999. It is manufactured by Sulzer Oscor and classified as a Class 3 device.
What It Is
The ht model ht pb is an inferior vena cava (IVC) filter designed to prevent pulmonary embolism by capturing emboli. It is intended for use in patients at risk of thromboembolic events.
Clinical Applications
Commonly used in patients who are at risk of developing pulmonary embolism, particularly those who cannot undergo anticoagulation therapy. It is also used in scenarios where there is a high risk of thromboembolic events.
Evidence Summary
The available literature includes 11 studies, encompassing various study types such as RCTs and meta-analyses, conducted between 2022 and 2025. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report varied outcomes, including the effectiveness of the device in preventing pulmonary embolism. However, specific efficacy data from the provided evidence is not detailed.
Safety Profile
Reported complications include potential risks associated with device implantation, though specific safety data from the provided evidence is not detailed.
Evidence Limitations
The evidence lacks detailed efficacy and safety outcomes specific to the ht model ht pb. Further research is needed to establish comprehensive clinical guidelines and long-term safety data.
Frequently Asked Questions
What are the clinical indications for ht model ht pb?
The device is indicated for use in patients at risk of pulmonary embolism, particularly when anticoagulation therapy is not feasible.
What outcomes have been reported in clinical studies?
Specific outcomes from the provided evidence are not detailed, but studies generally focus on the device's effectiveness in preventing pulmonary embolism.
What complications have been reported?
Safety data from the provided evidence is limited, but potential complications may include risks associated with device implantation.
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.