K161808 is an FDA 510(k) clearance for the Solution Set with 1.2 Micron Air Eliminating Filter. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on June 21, 2017, 355 days after receiving the submission on July 1, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K161808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2016 |
| Decision Date | June 21, 2017 |
| Days to Decision | 355 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 |