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FDA 510(k)

CentriMag Acute Circulatory Support System

K-Number: K191557 · 2019-07-10

ApplicantThoratec Corporation (Now Part of Abbott)
Decision Date2019-07-10
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CentriMag Acute Circulatory Support System is a medical device manufactured by Thoratec Corporation (Now Part of Abbott). It received FDA 510(k) clearance on 2019-07-10 under approval number K191557. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CentriMag Acute Circulatory Support System?

CentriMag Acute Circulatory Support System is a medical device that received FDA 510(k) clearance on 2019-07-10. It is manufactured by Thoratec Corporation (Now Part of Abbott). The 510(k) number is K191557.

When was CentriMag Acute Circulatory Support System approved by the FDA?

CentriMag Acute Circulatory Support System received FDA 510(k) clearance on 2019-07-10, under approval number K191557.

What company makes CentriMag Acute Circulatory Support System?

CentriMag Acute Circulatory Support System is manufactured by Thoratec Corporation (Now Part of Abbott).

What is the FDA product code for CentriMag Acute Circulatory Support System?

The FDA product code for CentriMag Acute Circulatory Support System is DWA.

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Related PubMed Literature

PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023) PMID: 33579597 Berlin Heart EXCOR and ACTION post-approval surveillance study report. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation (2021)

Related Devices (Code: DWA)

K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical , Ltd. K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation) K230698Anivia SG1000 Pump ConsoleApmtd, Inc. K221491Anivia SG1000 Pump ConsoleApmtd, Inc. K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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