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FDA 510(k)

CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR

K-Number: K131179 · 2013-07-18

ApplicantThoratec Corp
Decision Date2013-07-18
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Thoratec Corp. It received FDA 510(k) clearance on 2013-07-18 under 510(k) number K131179. 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 PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR?

CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR is a medical device that received FDA 510(k) clearance on 2013-07-18. The listed applicant is Thoratec Corp. The 510(k) number is K131179.

When did CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR receive FDA 510(k) clearance?

CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR received FDA 510(k) clearance on 2013-07-18, under 510(k) number K131179.

Who is the listed applicant for CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR?

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

What is the FDA product code for CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR?

The FDA product code for CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR is DWA.

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Official Source

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

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