K190806 is an FDA 510(k) clearance for the Flowart. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Asset Medikal Tasarim As. (Istanbul, TR). The FDA issued a Cleared decision on February 20, 2020, 328 days after receiving the submission on March 29, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K190806 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2019 |
| Decision Date | February 20, 2020 |
| Days to Decision | 328 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |