Submission Details
| 510(k) Number | K140469 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 25, 2014 |
| Decision Date | July 28, 2014 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
MR SYRINGE DUAL PACK
Jul 2014
Decision
153d
Days
Class 2
Risk
About This 510(k) Submission
K140469 is an FDA 510(k) clearance for the MR SYRINGE DUAL PACK, 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 July 28, 2014, 153 days after receiving the submission on February 25, 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
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