LC Bead LUMI
510(k) K162373
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162373 | Date16 Dec 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KRD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The LC Bead LUMI is a vascular embolization device designed to promote occlusion within blood vessels. Classified as a Device for Promoting Embolization, it is intended for use in interventional radiology and cardiovascular procedures to block abnormal blood flow, such as in arteriovenous malformations or hypervascular tumors.
Supplied as a single-use device, the LC Bead LUMI is intended for sterile use in controlled clinical settings. It is categorized under FDA regulation 870.3300 and has received a Traditional 510(k) clearance through the Cardiovascular Advisory Committee. The device is available in various sizes and configurations, as referenced by its associated FEI numbers, and is intended for use in procedures requiring precise vascular occlusion.
Other devices from Biocompatibles UK Ltd
Questions
AI-generated answers, 19 Sep 2026
What types of medical procedures is the LC Bead LUMI designed to assist with, and why is it specifically useful in those settings?
The LC Bead LUMI is designed for interventional radiology and cardiovascular procedures to block abnormal blood flow, such as in arteriovenous malformations (AVMs) or hypervascular tumors. Its purpose is to promote occlusion within blood vessels, making it particularly useful in cases where precise vascular control is required to stop unwanted blood supply to abnormal growths or abnormal connections between arteries and veins.
Is the LC Bead LUMI intended for single-use or repeated use, and why does this matter in clinical settings?
The LC Bead LUMI is supplied as a single-use device, intended for sterile use in controlled clinical settings. This design ensures patient safety by preventing cross-contamination between procedures, reducing the risk of infection, and maintaining consistent performance for each individual case.
How do I determine the correct size or configuration of LC Bead LUMI for a specific patient case?
The LC Bead LUMI comes in multiple sizes and configurations, each referenced by its FEI numbers (e.g., 2245304, 3002808761, etc.). These variations allow clinicians to select the appropriate bead size based on the vessel diameter and occlusion requirements of the procedure. Consulting the manufacturer’s technical documentation or a product catalog will help match the correct FEI number to the clinical scenario.
What regulatory pathway was followed for the LC Bead LUMI, and what does this mean for its use in clinical practice?
The LC Bead LUMI received a Traditional 510(k) clearance through the FDA’s Cardiovascular Advisory Committee, under regulation number 870.3300. This means it was deemed *substantially equivalent* to a legally marketed predicate device, confirming its safety and effectiveness for its intended use in promoting vascular embolization. Clinicians can rely on this clearance as evidence of regulatory review before use.