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FDA 510(k)

NEXFIN MODEL 2

K-Number: K122381 · 2013-04-22

ApplicantEdwards Lifesciences, LLC
Decision Date2013-04-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEXFIN MODEL 2 is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2013-04-22 under 510(k) number K122381. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXFIN MODEL 2?

NEXFIN MODEL 2 is a medical device that received FDA 510(k) clearance on 2013-04-22. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K122381.

When did NEXFIN MODEL 2 receive FDA 510(k) clearance?

NEXFIN MODEL 2 received FDA 510(k) clearance on 2013-04-22, under 510(k) number K122381.

Who is the listed applicant for NEXFIN MODEL 2?

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

What is the FDA product code for NEXFIN MODEL 2?

The FDA product code for NEXFIN MODEL 2 is DXN.

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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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