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FDA 510(k)

PACING KIT, TRANSMYOCARDIAL

K-Number: K770017 · 1977-01-14

ApplicantElectro-Catheter Corp.
Decision Date1977-01-14
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACING KIT, TRANSMYOCARDIAL 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 1977-01-14 under 510(k) number K770017. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACING KIT, TRANSMYOCARDIAL?

PACING KIT, TRANSMYOCARDIAL is a medical device that received FDA 510(k) clearance on 1977-01-14. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K770017.

When did PACING KIT, TRANSMYOCARDIAL receive FDA 510(k) clearance?

PACING KIT, TRANSMYOCARDIAL received FDA 510(k) clearance on 1977-01-14, under 510(k) number K770017.

Who is the listed applicant for PACING KIT, TRANSMYOCARDIAL?

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 PACING KIT, TRANSMYOCARDIAL?

The FDA product code for PACING KIT, TRANSMYOCARDIAL is DTR.

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Other records listing Electro-Catheter Corp. as applicant

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Related Devices (Code: DTR)

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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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