The following data is part of a premarket notification filed by 410 Medical, Inc. with the FDA for Lifeflow Blood System.
| Device ID | K191362 |
| 510k Number | K191362 |
| Device Name: | LifeFlow Blood System |
| Classification | Set, Administration, Intravascular |
| Applicant | 410 Medical, Inc. 201 West Main Street, Suite 207 Durham, NC 27701 |
| Contact | Galen Robertson |
| Correspondent | Danielle Besal MRC Global, LLC 9085 East Mineral Circle, Suite 110 Centennial, CO 80112 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-22 |
| Decision Date | 2020-05-20 |