The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Caresite Luer Access Device.
| Device ID | K140311 |
| 510k Number | K140311 |
| Device Name: | CARESITE LUER ACCESS DEVICE |
| Classification | Set, Administration, Intravascular |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Kimberly Smith |
| Correspondent | Kimberly Smith B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-07 |
| Decision Date | 2014-05-07 |
| Summary: | summary |