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510(k) K191557

CentriMag Acute Circulatory Support System by Thoratec Corporation (Now Part of Abbott) — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2019
Date Received
June 12, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

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