K232388 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 Ningbo Dizegens Medical Science Co.,Ltd (Ningbo, CN). The FDA issued a Cleared decision on November 21, 2023, 104 days after receiving the submission on August 9, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K232388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2023 |
| Decision Date | November 21, 2023 |
| Days to Decision | 104 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 |