The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Flowsmart Set/minimed Pro-set.
| Device ID | K181718 |
| 510k Number | K181718 |
| Device Name: | BD FlowSmart Set/MiniMed Pro-Set |
| Classification | Set, Administration, Intravascular |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Meriam Youssef |
| Correspondent | Meriam Youssef Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-29 |
| Decision Date | 2018-10-18 |
| Summary: | summary |