📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The available device record does not state a sufficiently specific FDA-cleared indication.
- The product code and device name alone should not be used to assign an indication such as IVC filter placement or cardiac pacing without reviewing the original FDA labeling.
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.
Practical Considerations
- Verify the original 510(k) summary, labeling, and instructions for use before clinical or historical classification.
- Do not infer MRI safety, implant duration, compatibility, or patient-selection criteria from the device name alone.
- Confirm the device category, dimensions, materials, and intended anatomy from the manufacturer documentation.
- Because this is an older device record, current availability and compatibility with contemporary equipment may be limited.
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.