K241109 is an FDA 510(k) clearance for the Single-use Sterile High-pressure Angiographic Syringes and Accessories. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Shenzhen Boon Medical Supply Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 22, 2024, 122 days after receiving the submission on April 22, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K241109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2024 |
| Decision Date | August 22, 2024 |
| Days to Decision | 122 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 |