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FDA 510(k)

FLOW DIRECTED THERMAL-DILUTION INFUSION

K-Number: K821057 · 1982-05-18

ApplicantOximetrix, Inc.
Decision Date1982-05-18
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOW DIRECTED THERMAL-DILUTION INFUSION is the device name listed in this FDA 510(k) record. The listed applicant is Oximetrix, Inc.. It received FDA 510(k) clearance on 1982-05-18 under 510(k) number K821057. 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 FLOW DIRECTED THERMAL-DILUTION INFUSION?

FLOW DIRECTED THERMAL-DILUTION INFUSION is a medical device that received FDA 510(k) clearance on 1982-05-18. The listed applicant is Oximetrix, Inc.. The 510(k) number is K821057.

When did FLOW DIRECTED THERMAL-DILUTION INFUSION receive FDA 510(k) clearance?

FLOW DIRECTED THERMAL-DILUTION INFUSION received FDA 510(k) clearance on 1982-05-18, under 510(k) number K821057.

Who is the listed applicant for FLOW DIRECTED THERMAL-DILUTION INFUSION?

The FDA 510(k) record lists Oximetrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLOW DIRECTED THERMAL-DILUTION INFUSION?

The FDA product code for FLOW DIRECTED THERMAL-DILUTION INFUSION is DYG.

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Other records listing Oximetrix, Inc. as applicant

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.

K853018MODEL 3000 OPTICATH COMPUTERK842622HEMO STATIC/ESU SCALPEL SYSTEMK833966PUMP INFUSION WEARABLE INFUSION PUMPK823007OPTICATH HEPARIN COATED, FLOW-DIRECTK821056FLOW DIRECTED THERMAL-DILUTION CATHETERK820674OPTICATH

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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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