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FDA 510(k)

ELECATH HEPARIN COATED THERMAL DILUTION

K-Number: K832787 · 1983-10-04

ApplicantElectro-Catheter Corp.
Decision Date1983-10-04
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ELECATH HEPARIN COATED 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 1983-10-04 under 510(k) number K832787. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECATH HEPARIN COATED THERMAL DILUTION?

ELECATH HEPARIN COATED THERMAL DILUTION is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K832787.

When did ELECATH HEPARIN COATED THERMAL DILUTION receive FDA 510(k) clearance?

ELECATH HEPARIN COATED THERMAL DILUTION received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832787.

Who is the listed applicant for ELECATH HEPARIN COATED 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 HEPARIN COATED THERMAL DILUTION?

The FDA product code for ELECATH HEPARIN COATED THERMAL DILUTION is KYG.

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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: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.

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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