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 ?
510(k)
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.
FDA-Cleared Indications
- Retrieval of an implanted inferior vena cava filter.
- Removal of an IVC filter when protection from pulmonary embolism is no longer required.
- Removal of an IVC filter when continued implantation may pose a risk to the patient.
Clinical Applications
- Percutaneous retrieval of a retrievable IVC filter.
- Removal of a temporary IVC filter after the risk of pulmonary embolism has decreased.
- IVC filter retrieval in an interventional radiology or vascular surgery procedure.
- Removal of an IVC filter when the treating clinician determines that retrieval is appropriate.
Practical Considerations
- Compatibility depends on the specific IVC filter, its position, tilt, embedment, and the retrieval system's labeled specifications.
- The procedure requires imaging guidance, typically fluoroscopy, and should be performed by clinicians trained in IVC filter retrieval.
- The patient should be evaluated for thrombus within the filter, filter fracture, penetration, migration, or other findings that may affect retrieval.
- The available FDA record does not establish MRI safety, device dimensions, or universal compatibility with all IVC filters; consult the original labeling before use.
- Retrieval may require an alternative endovascular technique or surgery if standard percutaneous removal is unsuccessful or unsafe.
Procedures that use this device
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.