The following data is part of a premarket notification filed by Maquet Cardiovascular Llc with the FDA for Fusion Vascular Graft And Fusion Bioline Vascular Graft.
| Device ID | K131778 |
| 510k Number | K131778 |
| Device Name: | FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | MAQUET CARDIOVASCULAR LLC 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Marylou Insinga |
| Correspondent | Marylou Insinga 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 | 2013-06-17 |
| Decision Date | 2013-11-14 |
| Summary: | summary |