The following data is part of a premarket notification filed by Maquet Cardiovascular, Llc with the FDA for Fusion Vascular Graft.
| Device ID | K153523 |
| 510k Number | K153523 |
| Device Name: | FUSION Vascular Graft |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | MAQUET CARDIOVASCULAR, LLC 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Mark Dinger |
| Correspondent | Mark Dinger MAQUET CARDIOVASCULAR, LLC 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-09 |
| Decision Date | 2016-02-16 |
| Summary: | summary |