The following data is part of a premarket notification filed by Thoratec Corp with the FDA for Centrimag Primary Console (2nd Generation); Mag Monitor.
| Device ID | K131179 |
| 510k Number | K131179 |
| Device Name: | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | THORATEC CORP 23 4th Ave Burlington, MA 01803 |
| Contact | Yverre Bobay |
| Correspondent | Yverre Bobay THORATEC CORP 23 4th Ave Burlington, MA 01803 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-25 |
| Decision Date | 2013-07-18 |
| Summary: | summary |