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FDA 510(k)

UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC

K-Number: K802968 · 1980-12-22

ApplicantTelectronics, Inc.
Decision Date1980-12-22
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K802968. 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 UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC?

UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Telectronics, Inc.. The 510(k) number is K802968.

When did UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC receive FDA 510(k) clearance?

UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC received FDA 510(k) clearance on 1980-12-22, under 510(k) number K802968.

Who is the listed applicant for UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC?

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

What is the FDA product code for UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC?

The FDA product code for UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC is DTB.

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Other records listing Telectronics, Inc. as applicant

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Related Devices (Code: DTB)

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.

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 VascularK031210MODEL 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.

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