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 |