The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Surecan Safety Ii Needle, Surecan Safety Ii Needle, Surecan Safety Ii Needle With Caresite Luer Access Device And Y Site.
| Device ID | K170897 |
| 510k Number | K170897 |
| Device Name: | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle With Caresite Luer Access Device And Y Site |
| Classification | Non-coring (huber) Needle |
| Applicant | B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| Contact | Angela J. Caravella |
| Correspondent | Angela J. Caravella B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| Product Code | PTI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-27 |
| Decision Date | 2017-11-03 |
| Summary: | summary |