|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
cardiohelp system
|
MAQUET CARDIOPULMONARY AG
|
K102726 |
04/04/2011
|
sorin c5 system; 85/c5 mast roller pump system 150(1x rp 150 and control panel with connecting cables); s5/c5 mast rolle
|
SORIN GROUP DEUTSCHLAND GMBH
|
K103762 |
01/20/2011
|
cardiohelp system
|
MAQUET CARDIOPULMONARY AG
|
K133598 |
05/21/2014
|
advanced perfusion system 1
|
TERUMO CARDIOVASCULAR SYSTEMS CORP.
|
K131041 |
02/20/2014
|
advanced perfusion system 1
|
Terumo Cardiovascular Systems Corporation
|
K153376 |
12/16/2015
|
advanced perfusion system 1
|
Terumo Cardiovascular Systems Corporation
|
K151349 |
08/27/2015
|
advanced perfusion system 1
|
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
|
K163531 |
06/07/2017
|
quantum pump console
|
Spectrum Medical Ltd
|
K173834 |
05/25/2018
|
advanced perfusion system 1
|
Terumo Cardiovascular Systems Corporation
|
K172220 |
08/17/2017
|
quantum smart occluder lh (left-hand), quantum smart occluder lh (right-hand)
|
Spectrum Medical Ltd
|
K190282 |
05/24/2019
|