K173361 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 June 26, 2018, 243 days after receiving the submission on October 26, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K173361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2017 |
| Decision Date | June 26, 2018 |
| Days to Decision | 243 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 |