K192657 is an FDA 510(k) clearance for the Sterile High-pressure Angiographic Syringes for Single-use. 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 7, 2020, 317 days after receiving the submission on September 25, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K192657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2019 |
| Decision Date | August 07, 2020 |
| Days to Decision | 317 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 |