The following data is part of a premarket notification filed by B. Braun Medical Inc with the FDA for Valved Safety Centesis Catheter.
| Device ID | K150800 |
| 510k Number | K150800 |
| Device Name: | Valved Safety Centesis Catheter |
| Classification | Needle, Catheter |
| Applicant | B. Braun Medical Inc 901 Marcon Blvd Allentown, PA 18109 |
| Contact | Nancy Skocypec |
| Correspondent | Nancy Skocypec B. Braun Medical Inc 901 Marcon Blvd Allentown, PA 18109 |
| Product Code | GCB |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-26 |
| Decision Date | 2015-11-12 |
| Summary: | summary |