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FDA 510(k)

Swan-Ganz catheter

K-Number: K233824 · 2024-06-06

ApplicantEdwards Lifesciences, LLC
Decision Date2024-06-06
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Swan-Ganz catheter is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2024-06-06 under approval number K233824. 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 Swan-Ganz catheter?

Swan-Ganz catheter is a medical device that received FDA 510(k) clearance on 2024-06-06. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K233824.

When was Swan-Ganz catheter approved by the FDA?

Swan-Ganz catheter received FDA 510(k) clearance on 2024-06-06, under approval number K233824.

What company makes Swan-Ganz catheter?

Swan-Ganz catheter is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Swan-Ganz catheter?

The FDA product code for Swan-Ganz catheter is DYG.

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Related Devices (Code: DYG)

K160084Swan Ganz CathetersEdwards Lifesciences, LLC K193466Swan-Ganz CathetersEdwards Lifesciences, LLC K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, 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

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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