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retrox rx 53-bp retrox rx 60-bp retrox rx 45-jbp retrox rx 53-jbp model numbers 124 396 124 397 124 395 124 000
Biotronik
Summary: The Retrox RX series by Biotronik are inferior vena cava (IVC) filters used to prevent pulmonary embolism. They are typically used by interventional radiologists or vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K981083 ↗
Decision Date
July 22, 1998
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Retrox RX series received FDA clearance via the 510(k) pathway on July 22, 1998. Manufactured by Biotronik, these devices are classified as Class III under product code DTB.
What It Is
The Retrox RX series are medical devices designed as inferior vena cava (IVC) filters. They are implanted into the IVC to capture blood clots and prevent them from reaching the lungs, thereby reducing the risk of pulmonary embolism. These devices are typically inserted via a minimally invasive procedure using a catheter.
Clinical Applications
The Retrox RX series is commonly used in patients at risk for venous thromboembolism, particularly those who cannot be managed with anticoagulation therapy. Interventional radiologists and vascular surgeons often use these devices in hospital settings, especially in patients with a history of deep vein thrombosis or those undergoing surgery with high thromboembolic risk.
Indications for Use
These IVC filters are indicated for patients who are at risk of developing pulmonary embolism, particularly when anticoagulation therapy is contraindicated or ineffective. They are used in conditions such as deep vein thrombosis or after certain surgeries.
Practical Considerations
The Retrox RX series comes in various sizes to accommodate different patient anatomies. Compatibility with standard catheterization techniques is essential for successful deployment. Clinicians should be aware of the retrieval options and timeframes if the filter is intended for temporary use.
Frequently Asked Questions
What is the Retrox RX series used for?
The Retrox RX series is used as an inferior vena cava filter to prevent pulmonary embolism in patients at risk of venous thromboembolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for patients at risk of pulmonary embolism, particularly when anticoagulation is contraindicated or ineffective.
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.