Submission Details
| 510(k) Number | K130142 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 22, 2013 |
| Decision Date | March 15, 2013 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
Cleared
Traditional
FLIXENE IFG VASCULAR GRAFT
Mar 2013
Decision
52d
Days
Class 2
Risk
About This 510(k) Submission
K130142 is an FDA 510(k) clearance for the FLIXENE IFG VASCULAR GRAFT, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Atrium Medical Corporation (Hudson, US). The FDA issued a Cleared decision on March 15, 2013, 52 days after receiving the submission on January 22, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.
Device Classification
| Product Code | DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3450 |
Manufacturer
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