FDA 510(k)

ENDOCARDIAL ELECTRODE

K-Number: K810928 · 1981-07-02

Decision Date1981-07-02

Product CodeDTB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ENDOCARDIAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Vitatron Medical BV. It received FDA 510(k) clearance on 1981-07-02 under 510(k) number K810928. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOCARDIAL ELECTRODE?

ENDOCARDIAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1981-07-02. The listed applicant is Vitatron Medical BV. The 510(k) number is K810928.

When did ENDOCARDIAL ELECTRODE receive FDA 510(k) clearance?

ENDOCARDIAL ELECTRODE received FDA 510(k) clearance on 1981-07-02, under 510(k) number K810928.

Who is the listed applicant for ENDOCARDIAL ELECTRODE?

The FDA 510(k) record lists Vitatron Medical BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOCARDIAL ELECTRODE?

The FDA product code for ENDOCARDIAL ELECTRODE is DTB.

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Other records listing Vitatron Medical BV as applicant

K854790CERYX PACEMAKER MODELS 114, 314 & 614 K844484HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA K844483TP 1 K844485CERYX6, 611, CERYX 3 311 & CERYX 1 111 K840668ELECTRODE PACEMAKER, PERM & TEMP K831860GENERATOR, PULSE, PACEMAKER #532

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Related Devices (Code: DTB)

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic Vascular K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, 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.