K213778 is an FDA 510(k) clearance for the IV Administration Set. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on March 3, 2022, 90 days after receiving the submission on December 3, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K213778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2021 |
| Decision Date | March 03, 2022 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |