đź“‹ FDA Reference
Pk-141 Patient Cable
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 ?
510(k)
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.
FDA-Cleared Indications
- For use in the retrieval of inferior vena cava filters.
- For use as a patient cable accessory with compatible IVC-filter retrieval equipment.
Clinical Applications
- Endovascular retrieval of a removable or retrievable IVC filter.
- Connection of compatible retrieval equipment during an IVC-filter removal procedure.
- Use in hospital-based interventional radiology or vascular surgery procedures when an IVC filter is no longer clinically needed and retrieval is indicated.
Practical Considerations
- Confirm compatibility with the specific IVC filter, retrieval system, and other procedural equipment before use.
- The cable should be handled according to the manufacturer’s instructions and used only by clinicians trained in IVC-filter retrieval.
- The FDA record and supplied information do not establish that the cable itself is MRI safe or MRI conditional; verify the current labeling before MRI exposure.
- Patient-specific contraindications and risks relate primarily to the IVC-filter retrieval procedure, including filter position, embedment, thrombus, vessel injury, bleeding, and contrast or anesthesia-related risks.
- This device is an accessory and does not determine whether an IVC filter should be retrieved; retrieval timing requires clinical assessment and imaging.
Procedures that use this device
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.