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FDA 510(k)

CARDIOHELP SYSTEM

K-Number: K102726 · 2011-04-04

ApplicantMaquet Cardiopulmonary, AG
Decision Date2011-04-04
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOHELP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiopulmonary, AG. It received FDA 510(k) clearance on 2011-04-04 under 510(k) number K102726. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOHELP SYSTEM?

CARDIOHELP SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-04. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K102726.

When did CARDIOHELP SYSTEM receive FDA 510(k) clearance?

CARDIOHELP SYSTEM received FDA 510(k) clearance on 2011-04-04, under 510(k) number K102726.

Who is the listed applicant for CARDIOHELP SYSTEM?

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

What is the FDA product code for CARDIOHELP SYSTEM?

The FDA product code for CARDIOHELP SYSTEM is DTQ.

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Other records listing Maquet Cardiopulmonary, AG as applicant

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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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