K213004 is an FDA 510(k) clearance for the Needle Free Connector. 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 May 10, 2022, 232 days after receiving the submission on September 20, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K213004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2021 |
| Decision Date | May 10, 2022 |
| Days to Decision | 232 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 |