FDA 510(k)

Swan-Ganz Catheters

K-Number: K193466 · 2020-02-16

Decision Date2020-02-16

Product CodeDYG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Swan-Ganz Catheters 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 2020-02-16 under 510(k) number K193466. 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 Catheters?

Swan-Ganz Catheters is a medical device that received FDA 510(k) clearance on 2020-02-16. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K193466.

When did Swan-Ganz Catheters receive FDA 510(k) clearance?

Swan-Ganz Catheters received FDA 510(k) clearance on 2020-02-16, under 510(k) number K193466.

Who is the listed applicant for Swan-Ganz Catheters?

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 Swan-Ganz Catheters?

The FDA product code for Swan-Ganz Catheters 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.

NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITING NCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITING NCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITING NCT03745313Edwards CLASP TR EFSCOMPLETED NCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITING NCT04375332Beating Heart Mitral Valve Repair With the HARPOON™ SystemACTIVE_NOT_RECRUITING

Other records listing Edwards Lifesciences, LLC as applicant

PMA P230013Percutaneously Delivered Prostheses and Tricuspid Valves PMA P860057replacement Heart-valve PMA P250019Prosthesis, mitral valve, percutaneously delivered PMA P220003Mitral valve repair devices PMA P200015Pulmonary valve prosthesis percutaneously delivered PMA P150048heart-valve, non-allograft tissue

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Related Devices (Code: DYG)

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 K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLC K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC K160084Swan 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.