The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Cadd Yellow High Volume Administration Set With Nrfit Connector.
| Device ID | K172592 |
| 510k Number | K172592 |
| Device Name: | CADD Yellow High Volume Administration Set With NRFit Connector |
| Classification | Administrations Sets With Neuraxial Connectors |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | Michael R. Johnson |
| Correspondent | Sunny Teekasingh Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Product Code | PWH |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-29 |
| Decision Date | 2018-05-17 |
| Summary: | summary |