Cleared Traditional

PreSep Oligon Oximetry Catheter

K160645 · Edwards Lifesciences, LLC · Cardiovascular
Jun 2016
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K160645 is an FDA 510(k) clearance for the PreSep Oligon Oximetry Catheter, a Catheter, Oximeter, Fiber-optic (Class II — Special Controls, product code DQE), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 16, 2016, 101 days after receiving the submission on March 7, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1230.

Submission Details

510(k) Number K160645 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2016
Decision Date June 16, 2016
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQE — Catheter, Oximeter, Fiber-optic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1230

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