Cleared Traditional

VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5

K100739 · Edwards Lifesciences, LLC · Cardiovascular
Dec 2010
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K100739 is an FDA 510(k) clearance for the VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5, a Probe, Thermodilution (Class II — Special Controls, product code KRB), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on December 7, 2010, 266 days after receiving the submission on March 16, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1915.

Submission Details

510(k) Number K100739 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2010
Decision Date December 07, 2010
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRB — Probe, Thermodilution
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1915

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