K173450 is an FDA 510(k) clearance for the PRESS DUO elite, PRESS DUO elite AG. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Nemoto Kyorindo Co., Ltd. (Bunkyo-Ku, JP). The FDA issued a Cleared decision on February 7, 2018, 93 days after receiving the submission on November 6, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K173450 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2017 |
| Decision Date | February 07, 2018 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |