The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Modification To Proxis System, Model Eps 101.
| Device ID | K063638 |
| 510k Number | K063638 |
| Device Name: | MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 |
| Classification | Catheter, Percutaneous |
| Applicant | ST. JUDE MEDICAL 6550 WEDGWOOD RD. NORTH SUITE 150 Maple Grove, MN 55311 |
| Contact | Shannon Springer |
| Correspondent | Shannon Springer ST. JUDE MEDICAL 6550 WEDGWOOD RD. NORTH SUITE 150 Maple Grove, MN 55311 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-07 |
| Decision Date | 2007-05-11 |
| Summary: | summary |