K202618 is an FDA 510(k) clearance for the IV Administration Sets. 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 September 24, 2021, 379 days after receiving the submission on September 10, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K202618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2020 |
| Decision Date | September 24, 2021 |
| Days to Decision | 379 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 |