The following data is part of a premarket notification filed by B.braun Medical Inc. with the FDA for Iv Administration Set.
| Device ID | K213778 |
| 510k Number | K213778 |
| Device Name: | IV Administration Set |
| Classification | Set, Administration, Intravascular |
| Applicant | B.Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| Contact | Tracy Larish |
| Correspondent | Tracy Larish B.Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-03 |
| Decision Date | 2022-03-03 |