The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Brk Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208.
| Device ID | K122587 |
| 510k Number | K122587 |
| Device Name: | BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 |
| Classification | Trocar |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Harlan Jones |
| Correspondent | Harlan Jones ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-24 |
| Decision Date | 2013-02-07 |
| Summary: | summary |