Device Classification Name |
Oxygenator, Cardiopulmonary Bypass
|
510(k) Number |
K190690 |
Device Name |
INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir |
Applicant |
SORIN GROUP ITALIA S.R.L. |
Via Statale 12 Nord, 86 |
Mirandola,
IT
41037
|
|
Applicant Contact |
Luigi Vecchi |
Correspondent |
LivaNova USA, Inc. |
14401 West 65th Way |
Arvada,
CO
80004
|
|
Correspondent Contact |
Scott Light |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 03/18/2019 |
Decision Date | 04/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|