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FDA 510(k)

ELECATH BALTHERM TLC THERMAL DILUTION

K-Number: K831945 · 1983-08-12

ApplicantElectro-Catheter Corp.
Decision Date1983-08-12
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECATH BALTHERM TLC THERMAL DILUTION is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Catheter Corp.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K831945. 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 ELECATH BALTHERM TLC THERMAL DILUTION?

ELECATH BALTHERM TLC THERMAL DILUTION is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K831945.

When did ELECATH BALTHERM TLC THERMAL DILUTION receive FDA 510(k) clearance?

ELECATH BALTHERM TLC THERMAL DILUTION received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831945.

Who is the listed applicant for ELECATH BALTHERM TLC THERMAL DILUTION?

The FDA 510(k) record lists Electro-Catheter Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECATH BALTHERM TLC THERMAL DILUTION?

The FDA product code for ELECATH BALTHERM TLC THERMAL DILUTION is DYG.

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Other records listing Electro-Catheter Corp. 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.

K934785MULTIPACEK943257TIP DEFLECTOR (GENESIS)K933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

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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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