|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
polystan heart lung machine sys
|
ADVOCACY INTERNATIONAL, LTD.
|
K813034 |
11/27/1981
|
quantum pump console
|
Spectrum Medical Ltd
|
K173834 |
05/25/2018
|
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
|
s3 cardioplegia control module version 2.0
|
MEDICAL DEVICE CONSULTANTS, INC.
|
K002116 |
08/09/2000
|
sarnes help
|
3M HEALTH CARE, SARNS
|
K772001 |
11/02/1977
|
sarns 7000 monitor module
|
3M HEALTH CARE, SARNS
|
K801097 |
05/20/1980
|
sarns 8000 modular perfusion system
|
3M HEALTH CARE, SARNS
|
K915183 |
07/08/1992
|
sarns 9000 heart-lung console
|
3M HEALTH CARE, SARNS
|
K871131 |
05/21/1987
|
sarns portable power module
|
3M HEALTH CARE, SARNS
|
K861388 |
06/23/1986
|