|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
essenz hlm, essenz ilbm
|
LivaNova Deutschland GmbH
|
K232291 |
08/24/2023
|
essenz hlm
|
LivaNova Deutschland GmbH
|
K221373 |
03/09/2023
|
centrimag pre-connected pack
|
Abbott
|
K222297 |
12/01/2022
|
terumo advanced perfusion system 1
|
Terumo Cardiovascular Systems Corporation
|
K221895 |
04/18/2023
|
stockert s5 system
|
LivaNova Deutschland GmbH
|
K210130 |
04/05/2021
|
century perfusion system
|
Century HLM, LLC
|
K202125 |
03/07/2021
|
quantum smart occluder lh (left-hand), quantum smart occluder lh (right-hand)
|
Spectrum Medical Ltd
|
K190282 |
05/24/2019
|
quantumn centrifugal drive- high pressure, quantum centrifugal drive- medium pressure
|
Spectrum Medical Ltd
|
K192838 |
04/13/2020
|
quantum pump console
|
Spectrum Medical Ltd
|
K173834 |
05/25/2018
|
advanced perfusion system 1
|
Terumo Cardiovascular Systems Corporation
|
K172220 |
08/17/2017
|