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FDA 510(k)

LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES

K-Number: K090004 · 2009-01-15

ApplicantLevitronix, LLC
Decision Date2009-01-15
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES is the device name listed in this FDA 510(k) record. The listed applicant is Levitronix, LLC. It received FDA 510(k) clearance on 2009-01-15 under 510(k) number K090004. 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 LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES?

LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES is a medical device that received FDA 510(k) clearance on 2009-01-15. The listed applicant is Levitronix, LLC. The 510(k) number is K090004.

When did LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES receive FDA 510(k) clearance?

LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES received FDA 510(k) clearance on 2009-01-15, under 510(k) number K090004.

Who is the listed applicant for LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES?

The FDA 510(k) record lists Levitronix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES?

The FDA product code for LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES is DWA.

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Other records listing Levitronix, LLC 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.

K110983CENTRIMAG DRAINAGE CANNULA KITK110980CENTRIMAG RETURN CANNULA KITK102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITORK093832LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLESK090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052K083340LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE

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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.K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation)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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