Cleared Traditional

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)

K172423 · Edwards Lifescience, LLC · Cardiovascular

Feb 2018

Decision

194d

Days

Class 2

Risk

About This 510(k) Submission

K172423 is an FDA 510(k) clearance for the PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter), a Catheter, Oximeter, Fiber-optic (Class II — Special Controls, product code DQE), submitted by Edwards Lifescience, LLC (Irvine, US). The FDA issued a Cleared decision on February 20, 2018, 194 days after receiving the submission on August 10, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1230.

Submission Details

510(k) Number	K172423 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 10, 2017
Decision Date	February 20, 2018
Days to Decision	194 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF