Submission Details
| 510(k) Number | K142745 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 24, 2014 |
| Decision Date | April 01, 2015 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
125mL CT Syringe
Apr 2015
Decision
189d
Days
Class 2
Risk
About This 510(k) Submission
K142745 is an FDA 510(k) clearance for the 125mL CT Syringe, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on April 1, 2015, 189 days after receiving the submission on September 24, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.
Device Classification
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1650 |
Manufacturer
Similar Devices — DXT Injector And Syringe, Angiographic
All 205
K251788 · Zhuhai DR Medical Instruments Co., Ltd.
· Mar 2026
K252891 · Bayer Medical Care, Inc.
· Feb 2026
K244038 · Shandong Int Medical Instruments Co., Ltd.
· Sep 2025
K242143 · Shandong Int Medical Instruments Co., Ltd.
· Dec 2024
K242212 · Nemoto Kyorindo Co., Ltd.
· Aug 2024
K241109 · Shenzhen Boon Medical Supply Co., Ltd.
· Aug 2024
More from Coeur, Inc.
View all
K170431
· DXT · Aug 2017
K161471
· DXT · Oct 2016
K150902
· DXT · Oct 2015
K140469
· DXT · Jul 2014
K133600
· DXT · Apr 2014