K241976 is an FDA 510(k) clearance for the nextaro® va, 15mm, 5µm. 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 September 6, 2024, 63 days after receiving the submission on July 5, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K241976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2024 |
| Decision Date | September 06, 2024 |
| Days to Decision | 63 days |
| Submission Type | Special |
| 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 |