Submission Details
| 510(k) Number | K150902 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 03, 2015 |
| Decision Date | October 22, 2015 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
330psi Extension Y-Line with Dual Check Valve
Oct 2015
Decision
202d
Days
Class 2
Risk
About This 510(k) Submission
K150902 is an FDA 510(k) clearance for the 330psi Extension Y-Line with Dual Check Valve, 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 October 22, 2015, 202 days after receiving the submission on April 3, 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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