Submission Details
| 510(k) Number | K120892 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 23, 2012 |
| Decision Date | June 10, 2013 |
| Days to Decision | 444 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
Cleared
Traditional
DISPOSABLE 330PSI EXTENSION LINES
Jun 2013
Decision
444d
Days
Class 2
Risk
About This 510(k) Submission
K120892 is an FDA 510(k) clearance for the DISPOSABLE 330PSI EXTENSION LINES, 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 June 10, 2013, 444 days after receiving the submission on March 23, 2012. 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
K142745
· DXT · Apr 2015
K140469
· DXT · Jul 2014