📋 FDA Reference
Low Profile Companion Sheath
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Summary: The Low Profile Companion Sheath is a medical device used in embolization procedures, primarily by interventional radiologists and vascular surgeons. It facilitates the delivery of embolization coils to treat vascular abnormalities.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K223872 ↗
Decision Date ?
January 19, 2023
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Low Profile Companion Sheath was cleared through the FDA 510(k) pathway on January 19, 2023. Manufactured by Merit Medical Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The Low Profile Companion Sheath is a specialized catheter designed to assist in the delivery of embolization coils during minimally invasive procedures. It features a low-profile design that allows for easier navigation through the vascular system, minimizing trauma to the vessel walls. This device is particularly useful in procedures requiring precise placement of embolic materials to occlude blood vessels.
FDA-Cleared Indications
- Used to facilitate the delivery of embolization coils during endovascular procedures.
- Intended for procedures in which targeted blood-vessel occlusion is required using embolization coils.
Clinical Applications
- Catheter-based embolization of selected blood vessels with embolization coils.
- Coil delivery for treatment of vascular abnormalities when vessel occlusion is clinically indicated.
- Endovascular procedures requiring a low-profile sheath for access and support during coil placement.
Practical Considerations
- Available configurations and sizes should be matched to the target vessel, access route, coil system, and procedural anatomy.
- Use requires fluoroscopic or other appropriate imaging guidance by trained clinicians.
- Compatibility with the intended embolization coils, guidewires, catheters, and other accessories should be confirmed before use.
- The device is not a treatment by itself; the embolization coil and the underlying condition determine the clinical objective.
- MRI safety information depends on the specific device configuration and labeling. Verify the current manufacturer instructions before MRI, and do not assume the sheath is MR Safe or MR Conditional.
Related Literature
The linked study examined the adverse events associated with the PrePex device for non-surgical male circumcision in Uganda. It highlighted the importance of device-based approaches in achieving public health targets for HIV prevention. While the study focused on a different device, it underscores the role of minimally invasive devices in improving procedural outcomes. Limitations include its focus on a specific population and procedure, which may not directly translate to the use of the Low Profile Companion Sheath.
Procedures that use this device
Frequently Asked Questions
What is the Low Profile Companion Sheath used for?
It is used for delivering embolization coils during vascular procedures to occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures requiring the delivery of coils to occlude blood vessels.
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.