The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for 6f Proxis System.
| Device ID | K073700 |
| 510k Number | K073700 |
| Device Name: | 6F PROXIS SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | ST. JUDE MEDICAL, INC. 6500 WEDGWOOD RD. NORTH Maple Grove, MN 55311 |
| Contact | Linh Pham |
| Correspondent | Linh Pham ST. JUDE MEDICAL, INC. 6500 WEDGWOOD RD. NORTH 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 | 2007-12-31 |
| Decision Date | 2008-10-02 |
| Summary: | summary |