The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Intellifuse Administration And Intellifuse Blood Administration Sets.
| Device ID | K192375 |
| 510k Number | K192375 |
| Device Name: | Intellifuse Administration And Intellifuse Blood Administration Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | Wendy Hills |
| Correspondent | Danielle Besal MRC/X, LLC 6075 Poplar Avenue, Suite 500 Memphis, TN 38119 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-30 |
| Decision Date | 2020-09-18 |