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FDA 510(k)

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)

K-Number: K172423 · 2018-02-20

ApplicantEdwards Lifescience, LLC
Decision Date2018-02-20
Product CodeDQE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifescience, LLC. It received FDA 510(k) clearance on 2018-02-20 under 510(k) number K172423. 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 PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)?

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) is a medical device that received FDA 510(k) clearance on 2018-02-20. The listed applicant is Edwards Lifescience, LLC. The 510(k) number is K172423.

When did PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) receive FDA 510(k) clearance?

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) received FDA 510(k) clearance on 2018-02-20, under 510(k) number K172423.

Who is the listed applicant for PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)?

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

What is the FDA product code for PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)?

The FDA product code for PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) is DQE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT01154465A Trial to Study the Influence of Ultrasound Guidance on the Complications of Central CatheterTERMINATEDNCT02279121ATAPAC Study (TauroLock Activity in Adult Cancer Patients)COMPLETEDNCT02798926Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?COMPLETEDNCT04559334Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN PatientsSUSPENDEDNCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITINGNCT05879835KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal FailureRECRUITING

Related Devices (Code: DQE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC

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.

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