The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Microvel Double Velour Supported 100.
| Device ID | K822633 |
| 510k Number | K822633 |
| Device Name: | MICROVEL DOUBLE VELOUR SUPPORTED 100 |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-31 |
| Decision Date | 1983-07-12 |