đź“‹ FDA Reference
pk-55 andover medical part 5455 label change
Biotronik, Gmbh &
Summary: The pk-55 Andover Medical Part 5455 is a medical device used for IVC filter retrieval, primarily by interventional radiologists and vascular surgeons. It is designed to assist in the safe and effective removal of inferior vena cava filters.
FDA Clearance Information
Pathway 510K
Number K901332 ↗
Decision Date May 9, 1990
Product Code DTC
Device Class Class 2
Evidence 0 studies
The pk-55 Andover Medical Part 5455 was cleared through the FDA 510(k) pathway on May 9, 1990. Manufactured by Biotronik, Gmbh &, it is classified as a Class 2 device under product code DTC.
What It Is
The pk-55 Andover Medical Part 5455 is a specialized medical device used for the retrieval of inferior vena cava (IVC) filters. IVC filters are small, cage-like devices placed in the IVC to prevent pulmonary embolism by capturing blood clots. This device facilitates the removal of these filters when they are no longer needed, ensuring patient safety and reducing the risk of complications associated with long-term filter placement.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly relevant in cases where temporary IVC filters have been placed in patients at risk of pulmonary embolism, such as those with deep vein thrombosis. The pk-55 Andover Medical Part 5455 is used in hospital settings, often in catheterization labs or operating rooms, and is suitable for adult patients who have had an IVC filter placed.
Indications for Use
The device is indicated for the retrieval of IVC filters, which are used in patients who are at risk for pulmonary embolism but cannot take anticoagulants. It is specifically used when the filter is no longer needed or if it poses a risk to the patient.
Practical Considerations
Clinicians should be aware of the typical sizing and compatibility of the pk-55 Andover Medical Part 5455 with various IVC filters. Proper technique is crucial to ensure safe retrieval, and familiarity with the device's operation is recommended for optimal outcomes.
Frequently Asked Questions
What is pk-55 Andover Medical Part 5455 used for?
It is used for the retrieval of inferior vena cava (IVC) filters, which are devices placed to prevent pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is cleared for the retrieval of IVC filters in patients who no longer require them or when the filter poses a risk.
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.