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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Oximeter, Fiber-Optic
510(k) Number K172423
Device Name PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
Applicant
Edwards Lifescience, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Bedalin T. Lugo Rodriguez
Correspondent
Edwards Lifescience, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Bedalin T. Lugo Rodriguez
Regulation Number870.1230
Classification Product Code
DQE  
Subsequent Product Code
DRE  
Date Received08/10/2017
Decision Date 02/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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