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FDA 510(k)

SWAN-GANZ FLOW-DIRECTED THERMODILUTION

K-Number: K810352 · 1981-03-27

ApplicantAmerican Edwards Laboratories
Decision Date1981-03-27
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ FLOW-DIRECTED THERMODILUTION is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1981-03-27 under 510(k) number K810352. 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 FLOW-DIRECTED THERMODILUTION?

SWAN-GANZ FLOW-DIRECTED THERMODILUTION is a medical device that received FDA 510(k) clearance on 1981-03-27. The listed applicant is American Edwards Laboratories. The 510(k) number is K810352.

When did SWAN-GANZ FLOW-DIRECTED THERMODILUTION receive FDA 510(k) clearance?

SWAN-GANZ FLOW-DIRECTED THERMODILUTION received FDA 510(k) clearance on 1981-03-27, under 510(k) number K810352.

Who is the listed applicant for SWAN-GANZ FLOW-DIRECTED THERMODILUTION?

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

What is the FDA product code for SWAN-GANZ FLOW-DIRECTED THERMODILUTION?

The FDA product code for SWAN-GANZ FLOW-DIRECTED THERMODILUTION is DYG.

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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, LLCK222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLCK193466Swan-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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