đź“‹ FDA Reference
Crux Snare Filter Retrieval Set
Summary: The Crux Snare Filter Retrieval Set is a medical device used for 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 ?
K133681 ↗
Decision Date ?
January 30, 2014
Product Code ?
MMX
Device Class ?
Class 2
Evidence ?
0 studies
The Crux Snare Filter Retrieval Set was cleared through the FDA's 510(k) pathway on January 30, 2014. Manufactured by Volcano, it is classified as a Class II device.
What It Is
The Crux Snare Filter Retrieval Set is designed to safely and effectively retrieve IVC filters that have been previously placed in patients to prevent pulmonary embolism. It consists of a snare mechanism that can be guided through the vasculature to capture and remove the filter. This device is crucial in managing complications or when the filter is no longer needed.
FDA-Cleared Indications
- Retrieval of previously placed Crux inferior vena cava filters.
- Removal of an IVC filter when filter retrieval is clinically indicated.
Clinical Applications
- Image-guided retrieval of a previously placed Crux IVC filter.
- Removal of a retrievable IVC filter after the temporary risk of pulmonary embolism has decreased.
- Removal of a Crux IVC filter when retrieval is clinically indicated by the treating physician.
Practical Considerations
- The set is intended for use with the Crux IVC filter; clinicians should confirm device and filter compatibility before the procedure.
- Retrieval is generally performed through venous access under fluoroscopic imaging, with local anesthesia and sedation or other anesthesia as clinically appropriate.
- The operator should evaluate filter position, tilt, embedment, thrombus, vessel injury and other findings before attempting retrieval.
- The record identifies the device as a Class II, 510(k)-cleared device under product code MMX; current manufacturer labeling should be reviewed for sizes, access requirements and contraindications.
- MRI safety depends on the implanted filter and its current labeling, not solely on the retrieval set. The retrieval set is removed during the procedure and is not intended to remain implanted.
Procedures that use this device
Frequently Asked Questions
What is Crux Snare Filter Retrieval Set used for?
It 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?
It is indicated for the retrieval of IVC filters in patients where filter removal is necessary.
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.