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510(k) K191557

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

K191557 is an FDA 510(k) premarket notification submitted by Thoratec Corporation (Now Part of Abbott) for the device "CentriMag Acute Circulatory Support System". The FDA issued a decision of Substantially Equivalent on July 10, 2019. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380.

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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  • K200306 — CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, C (March 6, 2020)
  • K131964 — BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE (July 24, 2013)
  • K131179 — CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR (July 18, 2013)
  • K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5) (September 20, 2011)
  • K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) (January 20, 2011)
  • K102129 — LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR (August 27, 2010)

FDA data resources