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FDA 510(k)

ELECATH VENTRICULAR PACING THERMAL DILUTION CATH

K-Number: K844022 · 1984-11-20

ApplicantElectro-Catheter Corp.
Decision Date1984-11-20
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECATH VENTRICULAR PACING THERMAL DILUTION CATH 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 1984-11-20 under 510(k) number K844022. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECATH VENTRICULAR PACING THERMAL DILUTION CATH?

ELECATH VENTRICULAR PACING THERMAL DILUTION CATH is a medical device that received FDA 510(k) clearance on 1984-11-20. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K844022.

When did ELECATH VENTRICULAR PACING THERMAL DILUTION CATH receive FDA 510(k) clearance?

ELECATH VENTRICULAR PACING THERMAL DILUTION CATH received FDA 510(k) clearance on 1984-11-20, under 510(k) number K844022.

Who is the listed applicant for ELECATH VENTRICULAR PACING THERMAL DILUTION CATH?

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 VENTRICULAR PACING THERMAL DILUTION CATH?

The FDA product code for ELECATH VENTRICULAR PACING THERMAL DILUTION CATH is DXG.

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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.

K934785MULTIPACEK933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK943257TIP DEFLECTOR (GENESIS)K933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

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Related Devices (Code: DXG)

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.

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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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