The following data is part of a premarket notification filed by Lumen Biomedical, Inc. with the FDA for Lbi Catheter System.
| Device ID | K053372 |
| 510k Number | K053372 |
| Device Name: | LBI CATHETER SYSTEM |
| Classification | Catheter, Embolectomy |
| Applicant | LUMEN BIOMEDICAL, INC. 2605 FERNBROOK LANE SUITE A Plymouth, MN 55447 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson LUMEN BIOMEDICAL, INC. 2605 FERNBROOK LANE SUITE A Plymouth, MN 55447 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-06-30 |
| Summary: | summary |