The following data is part of a premarket notification filed by Icu Medical with the FDA for Diana Chemoclave Transfer Set.
| Device ID | K190157 |
| 510k Number | K190157 |
| Device Name: | Diana ChemoClave Transfer Set |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | ICU Medical 600 Field Drive Lake Forest, IL 60045 |
| Contact | Jason Ma |
| Correspondent | Yuliya Matlin ICU Medical 600 N. Field Drive Lake Forest, IL 60045 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-30 |
| Decision Date | 2019-10-23 |
| Summary: | summary |