The following data is part of a premarket notification filed by Levitronix Llc. with the FDA for Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console.
Device ID | K081221 |
510k Number | K081221 |
Device Name: | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE |
Classification | Control, Pump Speed, Cardiopulmonary Bypass |
Applicant | LEVITRONIX LLC. 45 FIRST AVE. Waltham, MA 02451 |
Contact | Susan Hamann |
Correspondent | Susan Hamann LEVITRONIX LLC. 45 FIRST AVE. Waltham, MA 02451 |
Product Code | DWA |
CFR Regulation Number | 870.4380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-30 |
Decision Date | 2008-06-19 |
Summary: | summary |