K220558 is an FDA 510(k) clearance for the Blood Administration Sets. This device is classified as a Set, Blood Transfusion (Class II - Special Controls, product code BRZ).
Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on November 17, 2022, 262 days after receiving the submission on February 28, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K220558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2022 |
| Decision Date | November 17, 2022 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | BRZ — Set, Blood Transfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |