K171346 is an FDA 510(k) clearance for the Sapphire Sets. This device is classified as a Accessories, Pump, Infusion (Class II - Special Controls, product code MRZ).
Submitted by Icu Medical (Lake Forest, US). The FDA issued a Cleared decision on August 25, 2017, 109 days after receiving the submission on May 8, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K171346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2017 |
| Decision Date | August 25, 2017 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MRZ - Accessories, Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |