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 |