Cleared Special

PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)

K110167 · Edwards Lifesciences, LLC · Cardiovascular
Feb 2011
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K110167 is an FDA 510(k) clearance for the PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN), 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 February 18, 2011, 29 days after receiving the submission on January 20, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1230.

Submission Details

510(k) Number K110167 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2011
Decision Date February 18, 2011
Days to Decision 29 days
Submission Type Special
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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