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FDA 510(k)

VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5

K-Number: K100739 · 2010-12-07

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

Device Summary

VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 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 K100739. The device is classified under product code KRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5?

VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 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 K100739.

When did VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 receive FDA 510(k) clearance?

VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 received FDA 510(k) clearance on 2010-12-07, under 510(k) number K100739.

Who is the listed applicant for VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5?

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 VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5?

The FDA product code for VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 is KRB.

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Related Devices (Code: KRB)

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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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