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FDA 510(k)

myMerlin(TM) Mobile Application Model APP1001

K-Number: K173232 · 2017-11-02

ApplicantSt Jude Medical
Decision Date2017-11-02
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

myMerlin(TM) Mobile Application Model APP1001 is a medical device manufactured by St Jude Medical. It received FDA 510(k) clearance on 2017-11-02 under approval number K173232. The device is classified under product code MXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the myMerlin(TM) Mobile Application Model APP1001?

myMerlin(TM) Mobile Application Model APP1001 is a medical device that received FDA 510(k) clearance on 2017-11-02. It is manufactured by St Jude Medical. The 510(k) number is K173232.

When was myMerlin(TM) Mobile Application Model APP1001 approved by the FDA?

myMerlin(TM) Mobile Application Model APP1001 received FDA 510(k) clearance on 2017-11-02, under approval number K173232.

What company makes myMerlin(TM) Mobile Application Model APP1001?

myMerlin(TM) Mobile Application Model APP1001 is manufactured by St Jude Medical.

What is the FDA product code for myMerlin(TM) Mobile Application Model APP1001?

The FDA product code for myMerlin(TM) Mobile Application Model APP1001 is MXC.

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Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

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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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