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px 53 15-bp model 130 050 and px 60 15-bp model 130 051
Biotronik, Gmbh &
Summary: The px 53 15-bp and px 60 15-bp models by Biotronik are FDA-cleared inferior vena cava (IVC) filters. They are used to prevent pulmonary embolism in patients at risk, typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K000763 ↗
Decision Date
April 6, 2000
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The px 53 and px 60 15-bp models received FDA clearance through the 510(k) pathway on April 6, 2000. Manufactured by Biotronik, Gmbh &, these devices are classified as Class III under product code DTB.
What It Is
The px 53 15-bp and px 60 15-bp models are inferior vena cava (IVC) filters designed to prevent pulmonary embolism by capturing blood clots before they reach the lungs. These devices are typically inserted via a minimally invasive procedure through a catheter placed in a large vein, usually in the groin or neck. Once deployed, the filter expands to fit the diameter of the IVC and traps clots while allowing normal blood flow.
Clinical Applications
IVC filters like the px 53 and px 60 models are commonly used in patients who have contraindications to anticoagulation therapy or have experienced recurrent venous thromboembolism despite anticoagulation. They are often deployed in hospital settings, particularly in interventional radiology suites or operating rooms. The primary patient population includes those with deep vein thrombosis (DVT) at high risk for pulmonary embolism.
Indications for Use
These devices are indicated for patients who are at risk of pulmonary embolism, especially when anticoagulation is not an option or has failed. They are suitable for individuals with a history of DVT or those undergoing surgery or trauma with a high risk of clot formation.
Practical Considerations
The px 53 and px 60 models come in various sizes to accommodate different IVC diameters. Compatibility with standard catheter delivery systems is a key feature, allowing for straightforward deployment. Clinicians should be familiar with imaging techniques to ensure proper placement and positioning of the filter.
Frequently Asked Questions
What is px 53/60 15-bp used for?
These devices are used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use IVC filters like these in clinical practice.
What are the FDA-cleared indications?
These filters are indicated for patients at risk of pulmonary embolism, especially when anticoagulation therapy is not suitable or has failed.
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.