Device Classification Name |
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
|
510(k) Number |
K183623 |
Device Name |
LifeSPARC Pump, LifeSPARC Controller |
Applicant |
CardiacAssist Inc |
620 Alpha Drive |
Pittsburgh,
PA
15238
|
|
Applicant Contact |
Greg Johnson |
Correspondent |
CardiacAssist Inc |
620 Alpha Drive |
Pittsburgh,
PA
15238
|
|
Correspondent Contact |
Greg Johnson |
Regulation Number | 870.4360
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/26/2018 |
Decision Date | 07/09/2019 |
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
|
|
|