The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for B. Braun Tear-away Introducer Needle.
| Device ID | K171584 |
| 510k Number | K171584 |
| Device Name: | B. Braun Tear-Away Introducer Needle |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| Contact | Kimberly Smith |
| Correspondent | Kimberly Smith B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-31 |
| Decision Date | 2017-12-22 |
| Summary: | summary |