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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709098302 | K173477 | 000 |
| 10840619023734 | K173477 | 000 |
| 10840619023963 | K173477 | 000 |
| 10840619024007 | K173477 | 000 |
| 10840619024809 | K173477 | 000 |
| 10840619025820 | K173477 | 000 |
| 10840619033887 | K173477 | 000 |
| 10840619033948 | K173477 | 000 |
| 10840619053946 | K173477 | 000 |
| 10840619023710 | K173477 | 000 |
| 10840619023673 | K173477 | 000 |
| 10840619056480 | K173477 | 000 |
| 10840619023727 | K173477 | 000 |
| 10887709085494 | K173477 | 000 |
| 10887709090320 | K173477 | 000 |
| 10887709120577 | K173477 | 000 |
| 10887709121017 | K173477 | 000 |
| 10887709126388 | K173477 | 000 |
| 10887709123615 | K173477 | 000 |
| 10840619054783 | K173477 | 000 |
| 10840619070660 | K173477 | 000 |
| 10840619081192 | K173477 | 000 |
| 10887709121192 | K173477 | 000 |
| 10887709122311 | K173477 | 000 |
| 10887709122632 | K173477 | 000 |
| 10840619023789 | K173477 | 000 |
| 10840619024106 | K173477 | 000 |
| 10840619024113 | K173477 | 000 |
| 10840619025431 | K173477 | 000 |
| 10840619025745 | K173477 | 000 |
| 10887709098944 | K173477 | 000 |
| 10887709097176 | K173477 | 000 |
| 10887709087481 | K173477 | 000 |
| 10840619081208 | K173477 | 000 |
| 10840619081215 | K173477 | 000 |
| 10840619081239 | K173477 | 000 |
| 10840619081406 | K173477 | 000 |
| 10840619082489 | K173477 | 000 |
| 10840619082601 | K173477 | 000 |
| 10887709068817 | K173477 | 000 |
| 10887709081915 | K173477 | 000 |
| 10840619025851 | K173477 | 000 |