Device Classification Name |
controller, temperature, cardiopulmonary bypass
|
510(k) Number |
K191402 |
Device Name |
Heater-Cooler System 3T |
Applicant |
LivaNova Deutschland GmbH |
Lindberghstrasse 25 |
Munich,
DE
80939
|
|
Applicant Contact |
Scott Light |
Correspondent |
LivaNova USA, Inc. |
14491 West 65th Way |
Arvada,
CO
80004
|
|
Correspondent Contact |
Scott Light |
Regulation Number | 870.4250
|
Classification Product Code |
|
Date Received | 05/24/2019 |
Decision Date | 02/25/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|