The following data is part of a premarket notification filed by B. Braun Instruments with the FDA for Intravenous Transfer Set (intrafix).
| Device ID | K760380 |
| 510k Number | K760380 |
| Device Name: | INTRAVENOUS TRANSFER SET (INTRAFIX) |
| Classification | Catheter, Infusion |
| Applicant | B. BRAUN INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCY |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-05 |
| Decision Date | 1976-11-02 |