Submission Details
| 510(k) Number | K152978 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | October 09, 2015 |
| Decision Date | March 25, 2016 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
DeRoyal Angiography Kits
Mar 2016
Decision
168d
Days
Class 2
Risk
About This 510(k) Submission
K152978 is an FDA 510(k) clearance for the DeRoyal Angiography Kits, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on March 25, 2016, 168 days after receiving the submission on October 9, 2015. 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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