The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Cooley 2 Vascular Prosthesis Straight.
| Device ID | K812248 |
| 510k Number | K812248 |
| Device Name: | COOLEY 2 VASCULAR PROSTHESIS STRAIGHT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-11 |
| Decision Date | 1981-11-24 |