The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Actreen Hi-lite Cath, Actreen Hi-lite Set.
| Device ID | K180801 |
| 510k Number | K180801 |
| Device Name: | Actreen Hi-Lite Cath, Actreen Hi-Lite Set |
| Classification | Catheter, Urethral |
| Applicant | B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109 |
| Contact | Anita J. Nemeth |
| Correspondent | Anita J. Nemeth B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-28 |
| Decision Date | 2018-11-05 |
| Summary: | summary |