K230528 is an FDA 510(k) clearance for the Extension Set. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Medcaptain Life Science Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 1, 2023, 277 days after receiving the submission on February 27, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K230528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2023 |
| Decision Date | December 01, 2023 |
| Days to Decision | 277 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 |