K244038 is an FDA 510(k) clearance for the High Pressure Tubing. 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. (Shandong, CN). The FDA issued a Cleared decision on September 5, 2025, 249 days after receiving the submission on December 30, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K244038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2024 |
| Decision Date | September 05, 2025 |
| Days to Decision | 249 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 |