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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, blood, cardiopulmonary bypass, non-roller type
510(k) Number K183623
Device Name LifeSPARC Pump, LifeSPARC Controller
CardiacAssist Inc
620 Alpha Drive
Pittsburgh,  PA  15238
Applicant Contact Greg Johnson
CardiacAssist Inc
620 Alpha Drive
Pittsburgh,  PA  15238
Correspondent Contact Greg Johnson
Regulation Number870.4360
Classification Product Code
Subsequent Product Code
Date Received12/26/2018
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