LC Bead LUMI
Device, Vascular, For Promoting Embolization
BIOCOMPATIBLES UK LTD
The following data is part of a premarket notification filed by Biocompatibles Uk Ltd with the FDA for Lc Bead Lumi.
Pre-market Notification Details
| Device ID | K152157 |
| 510k Number | K152157 |
| Device Name: | LC Bead LUMI |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | BIOCOMPATIBLES UK LTD Chapman House, Farnham Business Park, Weydon Lane Farnham, GB Gu9 8ql |
| Contact | April Kent |
| Correspondent | Robert Lally BTG International, Inc. Five Tower Bridge, Suite 800 300 Barr Harbor Drive West Conshohocken, PA 19428 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-12-11 |
| Summary: | summary |
Trademark Results [LC Bead LUMI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LC BEAD LUMI 86533142 5407866 Live/Registered |
Biocompatibles UK Limited 2015-02-12 |
 LC BEAD LUMI 86361563 5306864 Live/Registered |
Biocompatibles UK Limited 2014-08-08 |
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