K230668 is an FDA 510(k) clearance for the Disposable High-pressure Extension Lines. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Precision Medical Plastics , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 14, 2024, 462 days after receiving the submission on March 10, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K230668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2023 |
| Decision Date | June 14, 2024 |
| Days to Decision | 462 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |