K183187 is an FDA 510(k) clearance for the nextaro Transfer System, nextaro va. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Sfm Medical Devices GmbH (Waechtersbach, DE). The FDA issued a Cleared decision on March 15, 2019, 116 days after receiving the submission on November 19, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K183187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2018 |
| Decision Date | March 15, 2019 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |