The following data is part of a premarket notification filed by Lumen Biomedical, Inc. with the FDA for Fibernet Embolic Protection System.
| Device ID | K082348 |
| 510k Number | K082348 |
| Device Name: | FIBERNET EMBOLIC PROTECTION SYSTEM |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | LUMEN BIOMEDICAL, INC. 14505 21ST AVE. NORTH SUITE 212 Plymouth, MN 55447 |
| Contact | Maria E Brittle |
| Correspondent | Maria E Brittle LUMEN BIOMEDICAL, INC. 14505 21ST AVE. NORTH SUITE 212 Plymouth, MN 55447 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-15 |
| Decision Date | 2008-11-18 |
| Summary: | summary |