Submission Details
| 510(k) Number | K050456 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 23, 2005 |
| Decision Date | June 17, 2005 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
Cleared
Traditional
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
Jun 2005
Decision
114d
Days
Class 2
Risk
About This 510(k) Submission
K050456 is an FDA 510(k) clearance for the MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on June 17, 2005, 114 days after receiving the submission on February 23, 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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