The following data is part of a premarket notification filed by Lumen Biomedical, Inc. with the FDA for Fibernet Embolic Protection Device.
| Device ID | K111987 |
| 510k Number | K111987 |
| Device Name: | FIBERNET EMBOLIC PROTECTION DEVICE |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | LUMEN BIOMEDICAL, INC. 10900 73RD AVE NORTH SUITE 150 Maple Grove, MN 55369 |
| Contact | Michelle Straight |
| Correspondent | Michelle Straight LUMEN BIOMEDICAL, INC. 10900 73RD AVE NORTH SUITE 150 Maple Grove, MN 55369 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-13 |
| Decision Date | 2011-08-17 |
| Summary: | summary |