PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

Catheter, Oximeter, Fiber-optic

EDWARDS LIFESCIENCES, LLC.

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Presep And Pediasat Oximetry Catheters And Vigileo Arterial Pressure Cardiac Output/oximetry Monitor.

Pre-market Notification Details

Device IDK053609
510k NumberK053609
Device Name:PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
ClassificationCatheter, Oximeter, Fiber-optic
Applicant EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
ContactDiane Peterson
CorrespondentDiane Peterson
EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
Product CodeDQE  
Subsequent Product CodeDRE
Subsequent Product CodeDXG
CFR Regulation Number870.1230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2005-12-27
Decision Date2006-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00690103197594 K053609 000
00690103176810 K053609 000
00690103197433 K053609 000
00690103197440 K053609 000
00690103197457 K053609 000
00690103197488 K053609 000
00690103197518 K053609 000
00690103197525 K053609 000
00690103197532 K053609 000
00690103197549 K053609 000
00690103197556 K053609 000
00690103197563 K053609 000
00690103197570 K053609 000
00690103197587 K053609 000
00690103163384 K053609 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.