K210335 is an FDA 510(k) clearance for the Blood Administration Set. 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 June 10, 2021, 125 days after receiving the submission on February 5, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K210335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2021 |
| Decision Date | June 10, 2021 |
| Days to Decision | 125 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 |