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FDA 510(k)

THERMAL DILUTION CATHETER

K-Number: K823484 · 1982-12-22

ApplicantInstrumentation Laboratory CO
Decision Date1982-12-22
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERMAL DILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1982-12-22 under 510(k) number K823484. 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 THERMAL DILUTION CATHETER?

THERMAL DILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1982-12-22. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K823484.

When did THERMAL DILUTION CATHETER receive FDA 510(k) clearance?

THERMAL DILUTION CATHETER received FDA 510(k) clearance on 1982-12-22, under 510(k) number K823484.

Who is the listed applicant for THERMAL DILUTION CATHETER?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMAL DILUTION CATHETER?

The FDA product code for THERMAL DILUTION CATHETER 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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