FDA 510(k)

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

K-Number: K053609 · 2006-02-28

Decision Date2006-02-28

Product CodeDQE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2006-02-28 under 510(k) number K053609. 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 AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR is a medical device that received FDA 510(k) clearance on 2006-02-28. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K053609.

When did PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR receive FDA 510(k) clearance?

PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR received FDA 510(k) clearance on 2006-02-28, under 510(k) number K053609.

Who is the listed applicant for PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

The FDA product code for PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR is DQE.

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Other records listing Edwards Lifesciences, LLC as applicant

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Related Devices (Code: DQE)

K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLC K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC K110167PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)Edwards Lifesciences, LLC K091268HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSHospira, Inc.K062999OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARINHospira, Inc.K061585OPTICATH CENTRAL VENOUS OXIMETRY CATHETERHospira, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.