The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Proxis System, Model Eps101.
| Device ID | K060651 |
| 510k Number | K060651 |
| Device Name: | PROXIS SYSTEM, MODEL EPS101 |
| Classification | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Applicant | ST. JUDE MEDICAL 6550 WEDGWOOD RD. NORTH SUITE 150 Maple Grove, MN 55311 |
| Contact | Kimberly Briggs |
| Correspondent | Kimberly Briggs ST. JUDE MEDICAL 6550 WEDGWOOD RD. NORTH SUITE 150 Maple Grove, MN 55311 |
| Product Code | NFA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-13 |
| Decision Date | 2006-09-13 |
| Summary: | summary |