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sx 53 15-bp model 124 853 sx 60 15-bp model 124 854
Biotronik
Summary: The sx 53 15-bp and sx 60 15-bp models by Biotronik are inferior vena cava (IVC) filters used to prevent pulmonary embolism in patients at risk. They are typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K991169 ↗
Decision Date
July 1, 1999
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
These devices were cleared through the FDA 510(k) pathway on July 1, 1999. Manufactured by Biotronik, they are classified as Class III medical devices.
What It Is
The sx 53 15-bp and sx 60 15-bp are IVC filters designed to capture blood clots and prevent them from reaching the lungs, thereby reducing the risk of pulmonary embolism. These devices are placed in the inferior vena cava, the large vein that carries blood from the lower body to the heart. They are typically used in patients who cannot take anticoagulant medications or in whom such medications are ineffective.
Clinical Applications
These IVC filters are commonly used in settings where patients are at high risk for venous thromboembolism, such as in trauma, post-surgical recovery, or in patients with deep vein thrombosis. Interventional radiologists and vascular surgeons often perform the procedure in hospital settings. The devices are particularly useful in patients who have contraindications to anticoagulation therapy.
Indications for Use
The FDA indications for these devices include prevention of recurrent pulmonary embolism in patients with a history of thromboembolic disease who cannot be managed with anticoagulation therapy. They are also indicated for patients with massive pulmonary embolism where recurrent embolism would be life-threatening.
Practical Considerations
These IVC filters are available in various sizes to accommodate different patient anatomies. They are typically inserted via a catheter through the femoral or jugular vein. Clinicians should be aware of potential complications such as filter migration or perforation.
Frequently Asked Questions
What is sx 53 15-bp & sx 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 these devices.
What are the FDA-cleared indications?
These devices are indicated for patients at risk of pulmonary embolism who cannot be treated with anticoagulation therapy.
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.