FDA 510(k)

Swan Ganz Catheters

K-Number: K160084 · 2016-05-03

Decision Date2016-05-03

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 2016-05-03 under 510(k) number K160084. 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 2016-05-03. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K160084.

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

Swan Ganz Catheters received FDA 510(k) clearance on 2016-05-03, under 510(k) number K160084.

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 K193466Swan-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.