Cleared Traditional

Flo Trac sensor, Volume View sensor

K152980 · Edwards Lifesciences, LLC · Cardiovascular
Jan 2016
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K152980 is an FDA 510(k) clearance for the Flo Trac sensor, Volume View sensor, a Transducer, Blood-pressure, Extravascular (Class II — Special Controls, product code DRS), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on January 19, 2016, 102 days after receiving the submission on October 9, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2850.

Submission Details

510(k) Number K152980 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2015
Decision Date January 19, 2016
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRS — Transducer, Blood-pressure, Extravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2850

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