K222766 is an FDA 510(k) clearance for the Disposable Extension Set. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Shandong Ande Healthcare Apparatus Co., Ltd. (Shandong, CN). The FDA issued a Cleared decision on April 12, 2024, 577 days after receiving the submission on September 13, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K222766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2022 |
| Decision Date | April 12, 2024 |
| Days to Decision | 577 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 |