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FDA 510(k)

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

K-Number: K200306 · 2020-03-06

ApplicantAbbott (Formerly Thoratec Corporation)
Decision Date2020-03-06
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit is the device name listed in this FDA 510(k) record. The listed applicant is Abbott (Formerly Thoratec Corporation). It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K200306. 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 Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit?

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Abbott (Formerly Thoratec Corporation). The 510(k) number is K200306.

When did CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit receive FDA 510(k) clearance?

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit received FDA 510(k) clearance on 2020-03-06, under 510(k) number K200306.

Who is the listed applicant for CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit?

The FDA 510(k) record lists Abbott (Formerly Thoratec Corporation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit?

The FDA product code for CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit is DWA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07510451The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic SurgeryRECRUITINGNCT07554599Nonoinvasive HPI in Beach-chair PositionNOT_YET_RECRUITING

Other records listing Abbott (Formerly Thoratec Corporation) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222038CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System

Related Devices (Code: DWA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.K230698Anivia SG1000 Pump ConsoleApmtd, Inc.K221491Anivia SG1000 Pump ConsoleApmtd, Inc.K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical , Ltd.K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)

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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