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maxim pf models 033-581 033-590
Telectronics Pacing Systems
Summary: The Maxim PF Models 033-581 and 033-590 are inferior vena cava (IVC) filters used to prevent pulmonary embolism in patients at risk. They are typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K961118 ↗
Decision Date
July 15, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Maxim PF Models 033-581 and 033-590 were cleared through the FDA 510(k) process on July 15, 1996. Manufactured by Telectronics Pacing Systems, these devices are classified as Class III under product code DTB.
What It Is
The Maxim PF Models 033-581 and 033-590 are medical devices designed as inferior vena cava (IVC) filters. They are implanted into the IVC to capture and prevent blood clots from traveling to the lungs, thereby reducing the risk of pulmonary embolism. These filters are typically used in patients who cannot receive anticoagulation therapy or have recurrent embolism despite anticoagulation.
Clinical Applications
These IVC filters are commonly used in emergency and elective settings where patients are at high risk for venous thromboembolism. Interventional radiologists and vascular surgeons often place these filters in patients with contraindications to anticoagulation or those who have experienced recurrent venous thromboembolism. They are used in both hospital and outpatient settings.
Indications for Use
The FDA indications for these devices include prevention of pulmonary embolism in patients with deep vein thrombosis (DVT) who cannot be treated with anticoagulants. They are also indicated for patients who have experienced recurrent embolism despite anticoagulation therapy.
Practical Considerations
These IVC filters come in various sizes to accommodate different patient anatomies. Placement typically requires fluoroscopic guidance to ensure proper positioning within the inferior vena cava. Compatibility with other vascular devices should be considered during planning.
Related Literature
The linked study investigated the effects of 2″-O-rhamnosyl icariside II, a compound from Epimedium sagittatum, on pulmonary fibrosis. The study found that this compound can ameliorate fibrosis by modulating the E-cadherin-mediated oxidative-epithelial mesenchymal transition axis. However, the study's relevance to IVC filters is limited, as it primarily focuses on cellular mechanisms in pulmonary fibrosis.
Frequently Asked Questions
What is Maxim PF Models 033-581 and 033-590 used for?
These devices are used as inferior vena cava filters to prevent pulmonary embolism in patients at risk.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use these devices.
What are the FDA-cleared indications?
These devices are indicated for preventing pulmonary embolism in patients with deep vein thrombosis who cannot receive anticoagulants or have recurrent embolism despite anticoagulation.
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.