The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Actreen Mini Intermittent Urinary Catheters.
| Device ID | K151772 |
| 510k Number | K151772 |
| Device Name: | Actreen Mini Intermittent Urinary Catheters |
| Classification | Catheter, Urethral |
| Applicant | B. BRAUN MEDICAL INC. 901 MARCON BLVD. Allentown, PA 18109 |
| Contact | Sierra M. Mertz |
| Correspondent | Sierra M. Mertz B. BRAUN MEDICAL INC. 901 MARCON BLVD. 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 | 2015-06-30 |
| Decision Date | 2016-02-09 |
| Summary: | summary |