PreSep Oligon Oximetry Catheter
K-Number: K160645 · 2016-06-16
ApplicantEdwards Lifesciences, LLC
Decision Date2016-06-16
Product CodeDQE
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PreSep Oligon Oximetry Catheter is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2016-06-16 under approval number K160645. The device is classified under product code DQE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PreSep Oligon Oximetry Catheter?
PreSep Oligon Oximetry Catheter is a medical device that received FDA 510(k) clearance on 2016-06-16. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K160645.
When was PreSep Oligon Oximetry Catheter approved by the FDA?
PreSep Oligon Oximetry Catheter received FDA 510(k) clearance on 2016-06-16, under approval number K160645.
What company makes PreSep Oligon Oximetry Catheter?
PreSep Oligon Oximetry Catheter is manufactured by Edwards Lifesciences, LLC.
What is the FDA product code for PreSep Oligon Oximetry Catheter?
The FDA product code for PreSep Oligon Oximetry Catheter is DQE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.