The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Chemoclave Cytotoxic Medication Preparation And Delivery System.
| Device ID | K173477 |
| 510k Number | K173477 |
| Device Name: | ChemoCLAVE Cytotoxic Medication Preparation And Delivery System |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | ICU Medical, Inc. 600 N. Field Drive Lake Forest, IL 60045 |
| Contact | Catherine E. Kang |
| Correspondent | Catherine E. Kang ICU Medical, Inc. 600 N. Field Drive Lake Forest, IL 60045 |
| Product Code | ONB |
| Subsequent Product Code | FPA |
| Subsequent Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-08-31 |
| Summary: | summary |