The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems, Inc. with the FDA for Bd Saf-t Prn Luer Activated Valve, Model 385100.
| Device ID | K013621 |
| 510k Number | K013621 |
| Device Name: | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 |
| Classification | Set, Administration, Intravascular |
| Applicant | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | Leslie Wood |
| Correspondent | Leslie Wood BECTON DICKINSON INFUSION THERAPY SYSTEMS, 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 | 2001-11-05 |
| Decision Date | 2002-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903851084 | K013621 | 000 |
| 50382903851008 | K013621 | 000 |
| 50382903851022 | K013621 | 000 |
| 50382903851015 | K013621 | 000 |
| 30382903851059 | K013621 | 000 |
| 50382903851046 | K013621 | 000 |
| 30382903851035 | K013621 | 000 |
| 50382903851060 | K013621 | 000 |