The following data is part of a premarket notification filed by River Medical, Inc. with the FDA for Smartflow I Administration Set.
| Device ID | K945298 |
| 510k Number | K945298 |
| Device Name: | SMARTFLOW I ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | RIVER MEDICAL, INC. 7737 KENAMAR CT. San Diego, CA 92121 |
| Contact | Mark Shannon |
| Correspondent | Mark Shannon RIVER MEDICAL, INC. 7737 KENAMAR CT. San Diego, CA 92121 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-31 |
| Decision Date | 1995-06-14 |