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FDA 510(k)

Swang-Ganz IQ pulmonary artery catheter

K-Number: K222117 · 2022-12-09

ApplicantEdwards Lifesiences, LLC
Decision Date2022-12-09
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Swang-Ganz IQ pulmonary artery catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesiences, LLC. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222117. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Swang-Ganz IQ pulmonary artery catheter?

Swang-Ganz IQ pulmonary artery catheter is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Edwards Lifesiences, LLC. The 510(k) number is K222117.

When did Swang-Ganz IQ pulmonary artery catheter receive FDA 510(k) clearance?

Swang-Ganz IQ pulmonary artery catheter received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222117.

Who is the listed applicant for Swang-Ganz IQ pulmonary artery catheter?

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

What is the FDA product code for Swang-Ganz IQ pulmonary artery catheter?

The FDA product code for Swang-Ganz IQ pulmonary artery catheter is DYG.

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.

NCT05591118Pulmonary Embolism - Thrombus Removal With Catheter-Directed TherapyRECRUITINGNCT06336655Physiology of Unloading VA ECMO TrialRECRUITINGNCT06713668Augmented Pacing for Shock in the Cardiac Intensive Care UnitACTIVE_NOT_RECRUITINGNCT07500025Categorizing Patient Risk for Tricuspid Regurgitation (TR) Intervention With Admittance Pulmonary Artery Catheter System (APACS)NOT_YET_RECRUITINGNCT07612683Pulmonary Artery Catheters in Cardiac SurgeryNOT_YET_RECRUITINGNCT07762560Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic ShockNOT_YET_RECRUITING

Other records listing Edwards Lifesiences, LLC as applicant

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.

K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

Related Devices (Code: DYG)

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.

K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards LifesciencesK233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)Edwards LifesciencesK233824Swan-Ganz catheterEdwards Lifesciences, LLCK231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLCK193466Swan-Ganz CathetersEdwards Lifesciences, LLCK160084Swan Ganz CathetersEdwards Lifesciences, LLC

Official Source

View on FDA Database →

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

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