510(k) Report

Devices descending from K060093

4 later devices reach Presep Oligon Oximetry Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC20161—
+1K110167Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)Edwards Lifesciences, LLC20111—
+2K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…Edwards Lifescience, LLC201801
+2K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC20120—