K203796 is an FDA 510(k) clearance for the Firefly Needleless Connector. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Puracath Medical, Inc. (Newark, US). The FDA issued a Cleared decision on July 30, 2021, 214 days after receiving the submission on December 28, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K203796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2020 |
| Decision Date | July 30, 2021 |
| Days to Decision | 214 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 |