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biotronik d2k unipolar pe-60 4
Biotronik Sales
Summary: The Biotronik D2K Unipolar PE-60 4 is a medical device used in the management of certain cardiovascular conditions. It is primarily utilized by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K833104 ↗
Decision Date
October 19, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biotronik D2K Unipolar PE-60 4 was cleared through the FDA 510(k) pathway on October 19, 1983. Manufactured by Biotronik Sales, it is classified as a Class III device.
What It Is
The Biotronik D2K Unipolar PE-60 4 is a medical device designed for use in cardiovascular procedures. As a unipolar device, it is typically involved in interventions that require precise electrical conduction or pacing. The device's design allows for integration into existing cardiac management systems, providing reliable performance in clinical settings.
Clinical Applications
This device is commonly used in procedures involving the placement of inferior vena cava (IVC) filters, particularly in patients at risk of pulmonary embolism. It is often employed in hospital settings, especially in cardiology and interventional radiology departments. The device is suitable for adult patients who require long-term management of thromboembolic disorders.
Indications for Use
The FDA indications suggest that this device is intended for patients who need interventions related to venous thromboembolism, such as those requiring IVC filters. It is particularly relevant for individuals with contraindications to anticoagulation therapy.
Practical Considerations
The Biotronik D2K Unipolar PE-60 4 is compatible with standard cardiac pacing systems and is available in various sizes to accommodate different patient anatomies. Clinicians should ensure proper sizing and placement technique to optimize device performance and patient outcomes.
Frequently Asked Questions
What is Biotronik D2K Unipolar PE-60 4 used for?
It is used for managing cardiovascular conditions, particularly in procedures involving IVC filters to prevent pulmonary embolism.
What specialties typically use this device?
Cardiologists and interventional radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring interventions related to venous thromboembolism, such as IVC filter placement.
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.