K063784 is an FDA 510(k) clearance for the DYE MANAGEMENT SYSTEM. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 16, 2007, 116 days after receiving the submission on December 21, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K063784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2006 |
| Decision Date | April 16, 2007 |
| Days to Decision | 116 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |