Submission Details
| 510(k) Number | K051799 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 05, 2005 |
| Decision Date | November 02, 2005 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
Nov 2005
Decision
120d
Days
Class 2
Risk
About This 510(k) Submission
K051799 is an FDA 510(k) clearance for the DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS, 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 November 2, 2005, 120 days after receiving the submission on July 5, 2005. 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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