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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 a medical device manufactured by Edwards Lifesiences, LLC. It received FDA 510(k) clearance on 2022-12-09 under approval 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. It is manufactured by Edwards Lifesiences, LLC. The 510(k) number is K222117.

When was Swang-Ganz IQ pulmonary artery catheter approved by the FDA?

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

What company makes Swang-Ganz IQ pulmonary artery catheter?

Swang-Ganz IQ pulmonary artery catheter is manufactured by Edwards Lifesiences, LLC.

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

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Other Devices by Edwards Lifesiences, LLC

K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

Related Devices (Code: DYG)

K160084Swan Ganz CathetersEdwards Lifesciences, LLC K193466Swan-Ganz CathetersEdwards Lifesciences, LLC K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLC K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards Lifesciences K233983Swan-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 Lifesciences K233824Swan-Ganz catheterEdwards 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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