The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984.
| Device ID | K070417 |
| 510k Number | K070417 |
| Device Name: | ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Laura Moen-ftacek |
| Correspondent | Laura Moen-ftacek ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-12 |
| Decision Date | 2007-06-05 |
| Summary: | summary |