Submission Details
| 510(k) Number | K133600 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 2013 |
| Decision Date | April 30, 2014 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
Apr 2014
Decision
156d
Days
Class 2
Risk
About This 510(k) Submission
K133600 is an FDA 510(k) clearance for the COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR, 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 30, 2014, 156 days after receiving the submission on November 25, 2013. 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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