K230343 is an FDA 510(k) clearance for the ProSeal™ Closed System Administration Set. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on November 3, 2023, 268 days after receiving the submission on February 8, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K230343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2023 |
| Decision Date | November 03, 2023 |
| Days to Decision | 268 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 |