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FDA 510(k)

EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M

K-Number: K100709 · 2010-12-07

ApplicantEdwards Lifesciences, LLC
Decision Date2010-12-07
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M 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 2010-12-07 under 510(k) number K100709. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M?

EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M is a medical device that received FDA 510(k) clearance on 2010-12-07. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K100709.

When did EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M receive FDA 510(k) clearance?

EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M received FDA 510(k) clearance on 2010-12-07, under 510(k) number K100709.

Who is the listed applicant for EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M?

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 EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M?

The FDA product code for EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M is DXG.

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Related Devices (Code: DXG)

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.

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Official Source

View on FDA Database →

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