The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for E-z Set Infusion Set/saf-t E-z Set Infusion Set.
| Device ID | K970259 |
| 510k Number | K970259 |
| Device Name: | E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | C.j. Welle |
| Correspondent | C.j. Welle BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-23 |
| Decision Date | 1997-04-08 |
| Summary: | summary |