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FDA 510(k)

POLYURETHANE THERMAL DILUTION CATHET

K-Number: K841876 · 1984-07-13

ApplicantWaters Instruments, Inc.
Decision Date1984-07-13
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYURETHANE THERMAL DILUTION CATHET is the device name listed in this FDA 510(k) record. The listed applicant is Waters Instruments, Inc.. It received FDA 510(k) clearance on 1984-07-13 under 510(k) number K841876. 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 POLYURETHANE THERMAL DILUTION CATHET?

POLYURETHANE THERMAL DILUTION CATHET is a medical device that received FDA 510(k) clearance on 1984-07-13. The listed applicant is Waters Instruments, Inc.. The 510(k) number is K841876.

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

POLYURETHANE THERMAL DILUTION CATHET received FDA 510(k) clearance on 1984-07-13, under 510(k) number K841876.

Who is the listed applicant for POLYURETHANE THERMAL DILUTION CATHET?

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

What is the FDA product code for POLYURETHANE THERMAL DILUTION CATHET?

The FDA product code for POLYURETHANE THERMAL DILUTION CATHET is DYG.

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Other records listing Waters Instruments, 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.

K053169RM3 RENAL PRESERVATION SYSTEMK042224RM3 RENAL PRESERVATION SYSTEMK971571RM3 RENAL PRESERVATION SYSTEM--CONTROL UNITK921519OXICOM-2100K911207OXICOMPLUSK863210VELCOM-100

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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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