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pk-141 patient cable
Biotronik
Summary: The pk-141 patient cable by Biotronik is a medical device used in the retrieval of inferior vena cava (IVC) filters. It is primarily used by interventional radiologists and vascular surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K083674 ↗
Decision Date
April 1, 2009
Product Code
DTC
Device Class
Class 2
Evidence
0 studies
The pk-141 patient cable was cleared through the FDA 510(k) pathway on April 1, 2009. Manufactured by Biotronik, it is classified as a Class 2 device under product code DTC.
What It Is
The pk-141 patient cable is a specialized medical device designed to assist in the retrieval of inferior vena cava (IVC) filters. These filters are typically placed in patients to prevent pulmonary embolism by capturing blood clots. The cable works by connecting to retrieval tools, allowing clinicians to safely and effectively remove the filters when they are no longer needed.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly relevant for patients who have had an IVC filter placed temporarily, such as those at transient risk of deep vein thrombosis. The cable facilitates the retrieval procedure, ensuring that the filter can be removed without complications.
Indications for Use
The pk-141 patient cable is indicated for use in the retrieval of IVC filters. It is specifically designed for patients who have had these filters placed to prevent blood clots from reaching the lungs and need them removed once the risk has subsided.
Practical Considerations
The pk-141 patient cable is compatible with standard retrieval tools used in IVC filter procedures. Clinicians should ensure proper sizing and compatibility with the specific filter model being retrieved. Familiarity with the retrieval technique is essential for safe and effective use.
Frequently Asked Questions
What is pk-141 patient cable used for?
The pk-141 patient cable is used for the retrieval of inferior vena cava (IVC) filters.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in the retrieval of IVC filters, which are used to prevent pulmonary embolism.
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.