The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Mini Spike Plus 6/8r.
| Device ID | K201469 |
| 510k Number | K201469 |
| Device Name: | Mini Spike Plus 6/8R |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109 |
| Contact | Angela J. Caravella |
| Correspondent | Angela J. Caravella B. Braun Medical Inc. 901 Marcon Boulevard 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 | 2020-06-03 |
| Decision Date | 2020-12-09 |