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 | K160651 |
| 510k Number | K160651 |
| Device Name: | BD FlowSmart Set, MiniMed Pro-Set |
| Classification | Set, Administration, Intravascular |
| Applicant | BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07666 |
| Contact | Matthew Trachtenberg |
| Correspondent | Matthew Trachtenberg BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07666 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-08 |
| Decision Date | 2016-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903286176 | K160651 | 000 |
| 50382903286169 | K160651 | 000 |
| 50382903286152 | K160651 | 000 |
| 50382903286145 | K160651 | 000 |
| 50382903286138 | K160651 | 000 |
| 00382903286126 | K160651 | 000 |
| 50382903286114 | K160651 | 000 |
| 50382903286107 | K160651 | 000 |