K221473 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 September 26, 2022, 129 days after receiving the submission on May 20, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K221473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2022 |
| Decision Date | September 26, 2022 |
| Days to Decision | 129 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 |