K211618 is an FDA 510(k) clearance for the Fluido Compact Blood and Fluid Warming System. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by The Surgical Company International B.V. (Amersfoort, NL). The FDA issued a Cleared decision on June 5, 2023, 740 days after receiving the submission on May 26, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K211618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2021 |
| Decision Date | June 05, 2023 |
| Days to Decision | 740 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LGZ - Warmer, Thermal, Infusion Fluid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |