K242143 is an FDA 510(k) clearance for the Angiography Injector. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Shandong Int Medical Instruments Co., Ltd. (Rizhao, CN). The FDA issued a Cleared decision on December 23, 2024, 154 days after receiving the submission on July 22, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K242143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2024 |
| Decision Date | December 23, 2024 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |