K223175 is an FDA 510(k) clearance for the lntravascular Administration Sets with Stopcock and Manifold. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on March 10, 2023, 150 days after receiving the submission on October 11, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K223175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2022 |
| Decision Date | March 10, 2023 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMG — Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |