FDA 510(k)

L-12, L-21, AND L-22 ELECTRODES

K-Number: K780569 · 1978-06-14

Decision Date1978-06-14

Product CodeDTB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

L-12, L-21, AND L-22 ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Coratomic, Inc.. It received FDA 510(k) clearance on 1978-06-14 under 510(k) number K780569. 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 L-12, L-21, AND L-22 ELECTRODES?

L-12, L-21, AND L-22 ELECTRODES is a medical device that received FDA 510(k) clearance on 1978-06-14. The listed applicant is Coratomic, Inc.. The 510(k) number is K780569.

When did L-12, L-21, AND L-22 ELECTRODES receive FDA 510(k) clearance?

L-12, L-21, AND L-22 ELECTRODES received FDA 510(k) clearance on 1978-06-14, under 510(k) number K780569.

Who is the listed applicant for L-12, L-21, AND L-22 ELECTRODES?

The FDA 510(k) record lists Coratomic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for L-12, L-21, AND L-22 ELECTRODES?

The FDA product code for L-12, L-21, AND L-22 ELECTRODES is DTB.

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Other records listing Coratomic, Inc. as applicant

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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.