The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Apex Compounding System Transfer Set.
| Device ID | K151423 |
| 510k Number | K151423 |
| Device Name: | APEX Compounding System Transfer Set |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | B. BRAUN MEDICAL INC. 901 MARCON BLVD. Allentown, PA 18109 |
| Contact | Tracy Maddock |
| Correspondent | Tracy Maddock B. BRAUN MEDICAL INC. 901 MARCON BLVD. Allentown, PA 18109 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-28 |
| Decision Date | 2016-02-19 |
| Summary: | summary |