The following data is part of a premarket notification filed by Icu Medical, Inc with the FDA for Dye Management System.
| Device ID | K063784 |
| 510k Number | K063784 |
| Device Name: | DYE MANAGEMENT SYSTEM |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123 |
| Contact | Martin Maier |
| Correspondent | Martin Maier ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-21 |
| Decision Date | 2007-04-16 |
| Summary: | summary |