The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Meadox Intra-aortic Graft.
| Device ID | K881283 |
| 510k Number | K881283 |
| Device Name: | MEADOX INTRA-AORTIC GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Madeleine Kendeffy |
| Correspondent | Madeleine Kendeffy MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-25 |
| Decision Date | 1988-05-26 |