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yp 45 15-bp yp 53 15-bp yp 60 15-bp
Biotronik
Summary: The yp 45 15-bp, yp 53 15-bp, and yp 60 15-bp are intravascular devices used as IVC filters. They are primarily used by interventional radiologists and vascular surgeons to prevent pulmonary embolism in patients with contraindications to anticoagulation.
FDA Clearance Information
Pathway
510K
Number
K993139 ↗
Decision Date
December 17, 1999
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
These devices were cleared through the FDA 510(k) pathway on December 17, 1999. Manufactured by Biotronik, they are classified as Class III medical devices under product code DTB.
What It Is
The yp 45 15-bp, yp 53 15-bp, and yp 60 15-bp are inferior vena cava (IVC) filters. These devices are designed to be placed in the IVC to capture blood clots and prevent them from reaching the lungs, thereby reducing the risk of pulmonary embolism. They are typically used in patients who cannot be treated with anticoagulants.
Clinical Applications
These IVC filters are commonly used in emergency and surgical settings, particularly in patients at high risk of venous thromboembolism who have contraindications to anticoagulation therapy. They are often employed in trauma patients, those undergoing major surgery, or individuals with a history of deep vein thrombosis. Interventional radiologists and vascular surgeons are the primary users of these devices.
Indications for Use
The FDA indications suggest that these devices are intended for patients at risk of pulmonary embolism, particularly when anticoagulation therapy is not suitable. This includes patients with active bleeding or those who are undergoing procedures where anticoagulation is temporarily contraindicated.
Practical Considerations
These IVC filters come in various sizes to accommodate different patient anatomies. They are designed for percutaneous insertion, typically via the femoral or jugular vein. Clinicians should be familiar with the imaging techniques required for proper placement and retrieval, if applicable.
Frequently Asked Questions
What is yp 45 15-bp, yp 53 15-bp, yp 60 15-bp used for?
These devices are used as IVC filters to prevent pulmonary embolism in patients who cannot receive anticoagulation therapy.
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 use in patients at risk of pulmonary embolism who cannot be treated with anticoagulants.
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.