The following data is part of a premarket notification filed by Lumen Biomedical, Inc. with the FDA for Xtract Catheter System.
| Device ID | K071529 |
| 510k Number | K071529 |
| Device Name: | XTRACT CATHETER SYSTEM |
| Classification | Catheter, Embolectomy |
| 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 | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-05 |
| Decision Date | 2007-08-10 |
| Summary: | summary |